RS-1000
FDA 510(k) clearance K911230 · decided 1993-06-09
Clearance details
- K-number
- K911230
- Device name
- RS-1000
- Applicant
- Cp Medical
- Decision
- Substantially Equivalent
- Date received
- 1991-03-20
- Decision date
- 1993-06-09
- Days to decision
- 812 days
- Clearance type
- Traditional
- Product code
- KOC
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Huntington Beach, CA, 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.