COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
FDA 510(k) clearance K022023 · decided 2003-01-07
Clearance details
- K-number
- K022023
- Device name
- COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
- Applicant
- Clinical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-20
- Decision date
- 2003-01-07
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- KLA
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.