The following data is part of a premarket notification filed by Medical Microwave Research Corp. with the FDA for Thermotron 918.
Device ID | K860082 |
510k Number | K860082 |
Device Name: | THERMOTRON 918 |
Classification | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat |
Applicant | MEDICAL MICROWAVE RESEARCH CORP. 808 PERSHING DR STE.104 Silver Spring, MD 20910 |
Contact | Lawrence E Larsen |
Correspondent | Lawrence E Larsen MEDICAL MICROWAVE RESEARCH CORP. 808 PERSHING DR STE.104 Silver Spring, MD 20910 |
Product Code | IOA |
CFR Regulation Number | 890.5275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-08 |
Decision Date | 1986-03-27 |