510(k) K933652
K933652 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. for the device "FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING". The FDA issued a decision of ST on May 18, 1994. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Repro-Med Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- May 18, 1994
- Date Received
- July 28, 1993
- 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