BUBBLE TOCO
FDA 510(k) clearance K920152 · decided 1993-05-26
Clearance details
- K-number
- K920152
- Device name
- BUBBLE TOCO
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-13
- Decision date
- 1993-05-26
- Days to decision
- 499 days
- Clearance type
- Traditional
- Product code
- HFM
- Device class
- 2
- Regulation number
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Midvale, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.