The following data is part of a premarket notification filed by Battle Creek Equipment Co. with the FDA for Thermophore Electric Fomentation Unit.
Device ID | K851237 |
510k Number | K851237 |
Device Name: | THERMOPHORE ELECTRIC FOMENTATION UNIT |
Classification | Pad, Heating, Powered |
Applicant | BATTLE CREEK EQUIPMENT CO. 307 WEST JACKSON ST. Battle Creek, MI 49017 |
Contact | John W Doty |
Correspondent | John W Doty BATTLE CREEK EQUIPMENT CO. 307 WEST JACKSON ST. Battle Creek, MI 49017 |
Product Code | IRT |
CFR Regulation Number | 890.5740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-27 |
Decision Date | 1985-07-29 |