The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sonicator Plus 940, Model Me940.
Device ID | K071137 |
510k Number | K071137 |
Device Name: | SONICATOR PLUS 940, MODEL ME940 |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Contact | Rob Fleming |
Correspondent | Rob Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
Product Code | IMG |
Subsequent Product Code | GZJ |
Subsequent Product Code | LIH |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-24 |
Decision Date | 2007-08-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816864020678 | K071137 | 000 |
00816864020661 | K071137 | 000 |
00816864020234 | K071137 | 000 |