FDA Inspection 1319428 — Apnomed, Inc.
The FDA completed an inspection of Apnomed, Inc. on May 28, 2026 in Bellevue, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23182 | ISO 13485:2016 Clause 7.5.8 | No documented system to assign unique device identification (UDI) |