The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Hotline Fluid Warmer.
| Device ID | K911383 |
| 510k Number | K911383 |
| Device Name: | HOTLINE FLUID WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | LEVEL 1 TECHNOLOGIES, INC. 8904 PADDOCK LN. Potomac, MD 20854 |
| Contact | Bernard Konopko |
| Correspondent | Bernard Konopko LEVEL 1 TECHNOLOGIES, INC. 8904 PADDOCK LN. Potomac, MD 20854 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315057865 | K911383 | 000 |
| 10695085002826 | K911383 | 000 |
| 10695085002833 | K911383 | 000 |
| 30695085002813 | K911383 | 000 |
| 35019315057841 | K911383 | 000 |
| 20695085407000 | K911383 | 000 |
| 20695085407505 | K911383 | 000 |
| 10695085408000 | K911383 | 000 |
| 30695085401005 | K911383 | 000 |
| 20695085403804 | K911383 | 000 |
| 10695085410805 | K911383 | 000 |
| 50695085002404 | K911383 | 000 |
| 50695085820909 | K911383 | 000 |
| 50695085820916 | K911383 | 000 |
| 50695085821098 | K911383 | 000 |
| 10695085002796 | K911383 | 000 |