510(k) K030382
K030382 is an FDA 510(k) premarket notification submitted by Selicor, Inc. for the device "SELITHERM, MODEL C100". The FDA issued a decision of Substantially Equivalent on Apr 1, 2003. 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. Selicor, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 1, 2003
- Date Received
- Feb 5, 2003
- 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