The following data is part of a premarket notification filed by Microwave Medical Systems, Inc. with the FDA for Qwik-1(tm) In-line Iv Fluid Warmer.
| Device ID | K914867 |
| 510k Number | K914867 |
| Device Name: | QWIK-1(TM) IN-LINE IV FLUID WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Contact | Richard S Grabowy |
| Correspondent | Richard S Grabowy MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1992-10-23 |