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 |