CLARUS MODEL 5197 SIGHTLITE— 510(k) K971455
Substantially EquivalentClarus Medical Systems, Inc.
FDA 510(k) clearance K971455 for CLARUS MODEL 5197 SIGHTLITE, Substantially Equivalent on 1997-05-20. Applicant: Clarus Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Clarus Medical Systems, Inc.
- Product code
- Code FTI
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code FTI
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