510(k) K942161
K942161 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "LOCKBOX". The FDA issued a decision of ST on August 2, 1994. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- August 2, 1994
- Date Received
- May 4, 1994
- 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