FDA product code MSG: Ophthalmoscopes, Replacement Batteries, Hand-Held
MSG is the FDA product code for ophthalmoscopes, replacement batteries, hand-held. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under MSG. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmoscopes, Replacement Batteries, Hand-Held |
| Device class | Class II |
| Regulation | 21 CFR 886.1570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MSG clearance
Top MSG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alexander Mfg. Co. | 2 | 1997-05-06 |
Most recent MSG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971108 | Alexander Mfg. Co. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P | 1997-05-06 | 41 |
| K970268 | Alexander Mfg. Co. | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY | 1997-03-31 | 67 |
Recalls for MSG devices
openFDA lists no recalls for product code MSG.
Frequently asked questions
What is FDA product code MSG?
MSG is the FDA product code for ophthalmoscopes, replacement batteries, hand-held. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel.
What device class is MSG?
Class II, regulation 21 CFR 886.1570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MSG?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most MSG clearances?
Alexander Mfg. Co. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MSG
- Run a recall and safety report across every MSG manufacturer
- Watch product code MSG 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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