510(k) K850792
K850792 is an FDA 510(k) premarket notification submitted by Janssen Pharmaceutica, Inc. for the device "ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Nov 13, 1985. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Janssen Pharmaceutica, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 1985
- Date Received
- Feb 26, 1985
- 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
- 510(k)