ADVANCE MODEL UDS-ADV
FDA 510(k) clearance K931574 · decided 1993-08-05
Clearance details
- K-number
- K931574
- Device name
- ADVANCE MODEL UDS-ADV
- Applicant
- Laborie Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-30
- Decision date
- 1993-08-05
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- EXQ
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.