The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Infusion Fluid Warmer.
Device ID | K883873 |
510k Number | K883873 |
Device Name: | INFUSION FLUID WARMER |
Classification | Warmer, Thermal, Infusion Fluid |
Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Contact | Al Iverson |
Correspondent | Al Iverson PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Product Code | LGZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-13 |
Decision Date | 1989-02-28 |