510(k) K860082
K860082 is an FDA 510(k) premarket notification submitted by Medical Microwave Research Corp. for the device "THERMOTRON 918". The FDA issued a decision of Substantially Equivalent on March 27, 1986. The device falls under product code IOA (Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5275.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1986
- Date Received
- January 8, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5275
- Review Panel
- PM
- Submission Type