510(k) K973732
K973732 is an FDA 510(k) premarket notification submitted by Pti for the device "MEGAPULSE II". The FDA issued a decision of Substantially Equivalent on Jan 23, 1998. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 1998
- Date Received
- Sep 30, 1997
- 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