SENSE-4BABY SYSTEM
FDA 510(k) clearance K132918 · decided 2013-11-22
Clearance details
- K-number
- K132918
- Device name
- SENSE-4BABY SYSTEM
- Applicant
- Sense4baby , Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-17
- Decision date
- 2013-11-22
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- La Jolla, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.