CIV-OB (PLUS)
FDA 510(k) clearance K103172 · decided 2011-03-11
Clearance details
- K-number
- K103172
- Device name
- CIV-OB (PLUS)
- Applicant
- Civnet Communication, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-28
- Decision date
- 2011-03-11
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Moshav Hemed, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.