The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Meditherm.
Device ID | K894152 |
510k Number | K894152 |
Device Name: | MEDITHERM |
Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 601 EAST BROADWAY SUITE 203-A Jefferson City, TN 37760 |
Contact | Barton Haggard |
Correspondent | Barton Haggard MEDICAL EQUIPMENT DESIGNS, INC. 601 EAST BROADWAY SUITE 203-A Jefferson City, TN 37760 |
Product Code | IMI |
CFR Regulation Number | 890.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-14 |
Decision Date | 1990-06-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MEDITHERM 75341071 not registered Dead/Abandoned |
TCP/RELIABLE INC. 1997-08-14 |