510(k) K013192
K013192 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SONICATOR PLUS 930, MODEL ME 930". The FDA issued a decision of Substantially Equivalent on October 17, 2001. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2001
- Date Received
- September 25, 2001
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type