510(k) K920438
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- October 22, 1993
- Date Received
- February 3, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Analytical Sampling
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type