The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Hygrotherm.
Device ID | K800443 |
510k Number | K800443 |
Device Name: | HYGROTHERM |
Classification | Stimulator, Caloric-water |
Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETP |
CFR Regulation Number | 874.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-28 |
Decision Date | 1980-03-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYGROTHERM 73816538 1587643 Dead/Cancelled |
SULZER-ESCHER WYSS GMBH 1989-08-02 |