The following data is part of a premarket notification filed by Enthermics Medical Systems, Inc. with the FDA for Dc Series Fluid Warming Cabinet, Dc Series Fluid Warming Cabinet.
| Device ID | K132202 |
| 510k Number | K132202 |
| Device Name: | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | ENTHERMICS MEDICAL SYSTEMS, INC. WEST 164 NORTH 9221 WATER ST. Menomonee Falls, WI 53051 |
| Contact | Adam Van Essen |
| Correspondent | Adam Van Essen ENTHERMICS MEDICAL SYSTEMS, INC. WEST 164 NORTH 9221 WATER ST. Menomonee Falls, WI 53051 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2013-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851962007374 | K132202 | 000 |
| 00851962007473 | K132202 | 000 |
| 00851962007435 | K132202 | 000 |
| 00851962007527 | K132202 | 000 |
| 00851962007497 | K132202 | 000 |
| 00851962007534 | K132202 | 000 |
| 00851962007503 | K132202 | 000 |
| 00851962007671 | K132202 | 000 |
| 00851962007664 | K132202 | 000 |
| 00851962007657 | K132202 | 000 |
| 00851962007640 | K132202 | 000 |
| 00851962007633 | K132202 | 000 |
| 00851962007626 | K132202 | 000 |
| 00851962007428 | K132202 | 000 |
| 00851962007442 | K132202 | 000 |
| 00851962007367 | K132202 | 000 |
| 00851962007350 | K132202 | 000 |
| 00851962007343 | K132202 | 000 |
| 00851962007336 | K132202 | 000 |
| 00851962007329 | K132202 | 000 |
| 00851962007312 | K132202 | 000 |
| 00851962007305 | K132202 | 000 |
| 00851962007237 | K132202 | 000 |
| 00851962007107 | K132202 | 000 |
| 00851962007091 | K132202 | 000 |
| 00851962007084 | K132202 | 000 |
| 00851962007459 | K132202 | 000 |
| 00851962007619 | K132202 | 000 |