510(k) K831953
K831953 is an FDA 510(k) premarket notification submitted by Cryosan, Inc. for the device "INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Jul 19, 1983. The device falls under product code FIR (Pump, Blood, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Cryosan, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 1983
- Date Received
- Jun 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Extra-Luminal
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type