The following data is part of a premarket notification filed by Ehti Medical Corp. with the FDA for Vasotherm.
Device ID | K962243 |
510k Number | K962243 |
Device Name: | VASOTHERM |
Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
Applicant | EHTI MEDICAL CORP. 2391 N.E. LOOP 410, STE #404 San Antonio, TX 78217 |
Contact | James B Bingham |
Correspondent | James B Bingham EHTI MEDICAL CORP. 2391 N.E. LOOP 410, STE #404 San Antonio, TX 78217 |
Product Code | IMJ |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-11 |
Decision Date | 1997-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VASOTHERM 73436588 1295931 Dead/Cancelled |
BCD Products, Incorporated 1983-07-28 |