The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator 710 (model Me710).
Device ID | K880901 |
510k Number | K880901 |
Device Name: | SONICATOR 710 (MODEL ME710) |
Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Contact | R. E Fleming |
Correspondent | R. 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 | 1988-03-02 |
Decision Date | 1988-03-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816864020722 | K880901 | 000 |