510(k) K962195
K962195 is an FDA 510(k) premarket notification submitted by Sunbeam Health Division for the device "HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3". The FDA issued a decision of Substantially Equivalent on November 27, 1996. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. Sunbeam Health Division has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 1996
- Date Received
- June 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Heating, Powered
- Device Class
- Class II
- Regulation Number
- 890.5740
- Review Panel
- PM
- Submission Type