The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator 720 (model Me720).
Device ID | K883228 |
510k Number | K883228 |
Device Name: | SONICATOR 720 (MODEL ME720) |
Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Contact | Robert E Fleming |
Correspondent | Robert E Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Product Code | IMI |
CFR Regulation Number | 890.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-01 |
Decision Date | 1988-08-18 |