The following data is part of a premarket notification filed by Cincinnati Sub-zero with the FDA for Hemotherm Model 400.
| Device ID | K811742 |
| 510k Number | K811742 |
| Device Name: | HEMOTHERM MODEL 400 |
| Classification | System, Thermal Regulating |
| Applicant | CINCINNATI SUB-ZERO 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-19 |
| Decision Date | 1981-08-13 |