OCR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lung Sound Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Medical specialty
- Cardiovascular
- FDA definition
- The lung sound monitor is intended for use in monitoring and recording lung sounds.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VRLXP, MODEL XP (K091732) | Deep Breeze , Ltd. | 2010-03-04 |
| VRIICU SYSTEM (K073582) | Deep Breeze , Ltd. | 2008-10-15 |
| VR LUNG ELECTROSONOGRAPH (K061495) | Deep Breeze , Ltd. | 2007-07-18 |
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Every clearance here is in the API, with alerts when new ones post.