510(k) K883873
K883873 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "INFUSION FLUID WARMER". The FDA issued a decision of Substantially Equivalent on February 28, 1989. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Pmt Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1989
- Date Received
- September 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Thermal, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type