ANALGRAPH
FDA 510(k) clearance K941801 · decided 1995-09-08
Clearance details
- K-number
- K941801
- Device name
- ANALGRAPH
- Applicant
- Sandhill Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-12
- Decision date
- 1995-09-08
- Days to decision
- 514 days
- Clearance type
- Traditional
- Product code
- KLA
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.