510(k) K862376
K862376 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "NEMECTROSON MODEL 2". The FDA issued a decision of Substantially Equivalent on July 23, 1986. The device falls under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1986
- Date Received
- June 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5290
- Review Panel
- PM
- Submission Type