Sense4Baby System Model B+ (MSA)
FDA 510(k) clearance K143114 · decided 2015-03-10
Clearance details
- K-number
- K143114
- Device name
- Sense4Baby System Model B+ (MSA)
- Applicant
- Airstrip Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-30
- Decision date
- 2015-03-10
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- LQK
- Device class
- 2
- Regulation number
- 884.2730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- La Jolla, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for m recall (Z-2829-2016) | AirStrip Technologies, Inc. | 2016-09-15 |