510(k) K926191
K926191 is an FDA 510(k) premarket notification submitted by Sigma for the device "SIGMA 7000 AND SIGMA70002". The FDA issued a decision of Substantially Equivalent on August 31, 1993. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sigma has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1993
- Date Received
- December 9, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type