FDA product code GZO: Device, Galvanic Skin Response Measurement
GZO is the FDA product code for device, galvanic skin response measurement. It is a Class II device, regulated under 21 CFR 882.1540 and reviewed by the Neurology panel. FDA has cleared 26 510(k) submissions under GZO, from 19 different applicants. The average 510(k) review took 140 days (median 99). FDA has posted 3 recalls for GZO devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Galvanic Skin Response Measurement |
| Device class | Class II |
| Regulation | 21 CFR 882.1540 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GZO clearance
Top GZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ld Technology, LLC | 3 | 2015-09-24 |
| Meridian Co., Ltd. | 3 | 2002-08-29 |
| Vibrant Health | 3 | 2002-05-02 |
| Biomeridian, Int. | 2 | 2006-01-13 |
| Medeia, Inc. | 1 | 2015-10-19 |
14 more applicants have GZO clearances. See the full list in Caduvo.
Most recent GZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150804 | Medeia, Inc. | QBioScan | 2015-10-19 | 207 |
| K152216 | Ld Technology, LLC | SudoC | 2015-09-24 | 48 |
| K141872 | Impeto Medical, Inc. | SUDOSCAN | 2014-11-21 | 133 |
| K131568 | Ld Technology, LLC | SUDO PATH | 2013-06-28 | 29 |
| K111308 | Zyto Technologies, Inc. | ZYTO HAND CRADLE | 2011-08-30 | 112 |
Recalls for GZO devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code GZO?
GZO is the FDA product code for device, galvanic skin response measurement. It is a Class II device, regulated under 21 CFR 882.1540 and reviewed by the Neurology panel.
What device class is GZO?
Class II, regulation 21 CFR 882.1540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GZO?
Across 26 cleared submissions the average was 140 days from receipt to decision (median 99).
Which companies have the most GZO clearances?
Ld Technology, LLC (3); Meridian Co., Ltd. (3); Vibrant Health (3); Biomeridian, Int. (2); Medeia, Inc. (1).
Have GZO devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2018-07-02.
Next steps
- Run an FDA pathway report with predicate devices for product code GZO
- Run a recall and safety report across every GZO manufacturer
- Watch product code GZO 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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