The following data is part of a premarket notification filed by Sims Level 1, Inc. with the FDA for Hotline 2 Fluid Warmer.
| Device ID | K001764 |
| 510k Number | K001764 |
| Device Name: | HOTLINE 2 FLUID WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | SIMS LEVEL 1, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Gabriel J Muraca Jr. |
| Correspondent | Gabriel J Muraca Jr. SIMS LEVEL 1, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-12 |
| Decision Date | 2000-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20695085402708 | K001764 | 000 |