FDA product code CBS: Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBS is the FDA product code for analyzer, gas, halothane, gaseous-phase (anesthetic conc.). It is a Class II device, regulated under 21 CFR 868.1620 and reviewed by the Anesthesiology panel. FDA has cleared 17 510(k) submissions under CBS, from 15 different applicants. The average 510(k) review took 131 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| Device class | Class II |
| Regulation | 21 CFR 868.1620 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CBS clearance
Top CBS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datex Division Instrumentarium Corp. | 3 | 1995-02-14 |
| Datascope Corp. | 1 | 1998-03-13 |
| Pace Tech, Inc. | 1 | 1996-07-01 |
| Datex Medical Instrumentation, Inc. | 1 | 1996-05-03 |
| Riken Keiki Co., Ltd. | 1 | 1995-08-02 |
10 more applicants have CBS clearances. See the full list in Caduvo.
Most recent CBS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974903 | Datascope Corp. | GAS MODULE II, MODEL 0998-00-0143 | 1998-03-13 | 72 |
| K953795 | Pace Tech, Inc. | VITALMAX 4100 | 1996-07-01 | 322 |
| K960490 | Datex Medical Instrumentation, Inc. | AS/3 COMPACT AIRWAY MODULE M-CAIOV | 1996-05-03 | 91 |
| K951366 | Riken Keiki Co., Ltd. | RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) | 1995-08-02 | 128 |
| K950101 | Marquette Electronics, Inc. | RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR | 1995-03-21 | 69 |
Recalls for CBS devices
openFDA lists no recalls for product code CBS.
Frequently asked questions
What is FDA product code CBS?
CBS is the FDA product code for analyzer, gas, halothane, gaseous-phase (anesthetic conc.). It is a Class II device, regulated under 21 CFR 868.1620 and reviewed by the Anesthesiology panel.
What device class is CBS?
Class II, regulation 21 CFR 868.1620. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBS?
Across 17 cleared submissions the average was 131 days from receipt to decision (median 91).
Which companies have the most CBS clearances?
Datex Division Instrumentarium Corp. (3); Datascope Corp. (1); Pace Tech, Inc. (1); Datex Medical Instrumentation, Inc. (1); Riken Keiki Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBS
- Run a recall and safety report across every CBS manufacturer
- Watch product code CBS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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