NHM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sheet, Recording, Breast Examination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2990
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SAFETOUCH (K022861) | Rusin Medical Devices | 2002-11-26 |
| SAFETOUCH (K014300) | James D Rusin MD, MBA | 2002-03-01 |
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Every clearance here is in the API, with alerts when new ones post.