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Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901036 · UDI-DI 00732094082319
10
510(k) clearances
6
Adverse events
1
Recalls
14
Facilities
Description
Welch Allyn AM282 Manual Audiometer with 11 Frequencies (125 Hz to 8,000 Hz), Audiometry Headset (External), Threshold Audiometry Card, Audiogram Forms (Qty. 50), Soft Storage Case; 100-240 V, 50-60 Hz AC, IEC Plug Type-B
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-06-27 | Natus Medical Inc | Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.