AIR-CUSHION TOCOTONOMETER
FDA 510(k) clearance K860933 · decided 1986-07-09
Clearance details
- K-number
- K860933
- Device name
- AIR-CUSHION TOCOTONOMETER
- Applicant
- International Biomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-12
- Decision date
- 1986-07-09
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- HFM
- Device class
- 2
- Regulation number
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.