CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
FDA 510(k) clearance K971584 · decided 1997-05-23
Clearance details
- K-number
- K971584
- Device name
- CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
- Applicant
- Clarus Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-30
- Decision date
- 1997-05-23
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- OCV
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.