BIRTHTRACK (A.K.A. CLM)
FDA 510(k) clearance K082704 · decided 2009-01-09
Clearance details
- K-number
- K082704
- Device name
- BIRTHTRACK (A.K.A. CLM)
- Applicant
- Barnev, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-16
- Decision date
- 2009-01-09
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- NPB
- Device class
- 2
- Regulation number
- 884.2800
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Kfar Saba, IL
- 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 |
|---|---|---|
| LABORPRO SYSTEM (K081984) | Trig Medical, Ltd. | 2009-03-04 |
| BIRTHTRACK (K080672) | Barnev, Ltd. | 2008-07-08 |
| COMPUTERIZED LABOR MONITORING SYSTEM (DEN060006) | Barnev, Ltd. | 2007-01-30 |
Recalls involving this device
No recalls on record reference this clearance.