Panels › Ear, Nose, Throat › Product code ERA · Class 1
Otoscope
Regulation 874.4770
0510(k)s in 12 months (56 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in ERA
| Company | 510(k)s | Recalls |
|---|---|---|
| Rudolf Riester GmbH & Co. KG | 9 | 0 |
| Welch Allyn, Inc. | 9 | 0 |
| Jedmed Instrument Co. | 4 | 0 |
| Pedia Pals, Inc. | 3 | 0 |
| Artiberia | 2 | 0 |
| Conphar, Inc. | 2 | 0 |
| Introspect, Inc. | 2 | 0 |
| Oticon Corp. | 2 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Blue Focus | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 1981 | K813003 | P.P.P. TREATMENT CABINET Precision Professional Products | ERA |
| Mar 10, 1980 | K800365 | EARSCOPE Nash & Assoc. | ERA |
| Jan 26, 1979 | K782142 | ILLIMINATOR, MODEL 265 NASAL Welch Allyn, Inc. | ERA |
| Jun 28, 1978 | K781029 | OTOSCOPE, DIAG. MODELS 20100 & 20200 Welch Allyn, Inc. | ERA |
| Apr 29, 1977 | K770770 | WALL CHARGER, MODEL #79111 Welch Allyn, Inc. | ERA |
| Apr 29, 1977 | K770769 | OTOSCOPE/ILLUMINATOR, MODEL #21100 Welch Allyn, Inc. | ERA |
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