The following data is part of a premarket notification filed by Emit Corporation with the FDA for Hypothermx Intravenous Fluid Warmer.
| Device ID | K103801 |
| 510k Number | K103801 |
| Device Name: | HYPOTHERMX INTRAVENOUS FLUID WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | EMIT CORPORATION 42 NORTH CHATSONG CIRCLE Woodlands, TX 77382 |
| Contact | Darla J Elkin |
| Correspondent | Darla J Elkin EMIT CORPORATION 42 NORTH CHATSONG CIRCLE Woodlands, TX 77382 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-28 |
| Decision Date | 2011-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003277042 | K103801 | 000 |
| 00850003277035 | K103801 | 000 |