SYSTEMS FLOW 2000
FDA 510(k) clearance K902993 · decided 1990-12-24
Clearance details
- K-number
- K902993
- Device name
- SYSTEMS FLOW 2000
- Applicant
- Universal Hydrotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-09
- Decision date
- 1990-12-24
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.