TRANSDUCER PROTECTOR
FDA 510(k) clearance K912394 · decided 1991-08-30
Clearance details
- K-number
- K912394
- Device name
- TRANSDUCER PROTECTOR
- Applicant
- Filtertek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-28
- Decision date
- 1991-08-30
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- FIB
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hebron, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.