BABYCARE
FDA 510(k) clearance K023082 · decided 2003-03-03
Clearance details
- K-number
- K023082
- Device name
- BABYCARE
- Applicant
- Bionet Company, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-17
- Decision date
- 2003-03-03
- Days to decision
- 167 days
- Clearance type
- Abbreviated
- Product code
- HEP
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Alpharetta, GA, 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 |
|---|---|---|
| SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (K101960) | Edan Instruments, Inc. | 2010-08-10 |
| ULTRACELL INSTRUMENT WIPE (K920353) | Ultracell Medical Technologies, Inc. | 1992-09-15 |
| POCKET DOP 3 (K910462) | Imex Medical Systems, Inc. | 1991-06-24 |
Recalls involving this device
No recalls on record reference this clearance.