VRLXP, MODEL XP
FDA 510(k) clearance K091732 · decided 2010-03-04
Clearance details
- K-number
- K091732
- Device name
- VRLXP, MODEL XP
- Applicant
- Deep Breeze , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-11
- Decision date
- 2010-03-04
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- OCR
- Device class
- 2
- Regulation number
- 870.1875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VRIICU SYSTEM (K073582) | Deep Breeze , Ltd. | 2008-10-15 |
| VR LUNG ELECTROSONOGRAPH (K061495) | Deep Breeze , Ltd. | 2007-07-18 |
Recalls involving this device
No recalls on record reference this clearance.