The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-cal 370 Heater/cooler.
| Device ID | K894980 |
| 510k Number | K894980 |
| Device Name: | BIO-CAL 370 HEATER/COOLER |
| Classification | System, Thermal Regulating |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnsen |
| Correspondent | Thomas K Johnsen BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978537474 | K894980 | 000 |
| 00673978537467 | K894980 | 000 |