The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Bt 794-blood/fluid Warmer.
| Device ID | K822098 |
| 510k Number | K822098 |
| Device Name: | BT 794-BLOOD/FLUID WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-16 |
| Decision Date | 1982-08-20 |