VRIICU SYSTEM
FDA 510(k) clearance K073582 · decided 2008-10-15
Clearance details
- K-number
- K073582
- Device name
- VRIICU SYSTEM
- Applicant
- Deep Breeze , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-20
- Decision date
- 2008-10-15
- Days to decision
- 300 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 |
|---|---|---|
| VRLXP, MODEL XP (K091732) | Deep Breeze , Ltd. | 2010-03-04 |
| VR LUNG ELECTROSONOGRAPH (K061495) | Deep Breeze , Ltd. | 2007-07-18 |
Recalls involving this device
No recalls on record reference this clearance.