The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc. with the FDA for Hemotherm Model 400ce Cooler/heater System.
| Device ID | K122813 |
| 510k Number | K122813 |
| Device Name: | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati, OH 45241 |
| Contact | Steven J Berke |
| Correspondent | Steven J Berke CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati, OH 45241 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2012-12-18 |
| Summary: | summary |