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 |