ACEM
FDA 510(k) clearance K111013 · decided 2011-12-19
Clearance details
- K-number
- K111013
- Device name
- ACEM
- Applicant
- Sandhill Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-11
- Decision date
- 2011-12-19
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- FFZ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELECTRIC CORD FOR ENDOSCOPE (K822254) | Kelleher Corp. | 1982-08-20 |
| C-CORD (K782046) | Concept, Inc. | 1979-01-10 |
Recalls involving this device
No recalls on record reference this clearance.