510(k) K963887
K963887 is an FDA 510(k) premarket notification submitted by Anthony A. Chiurco for the device "PT-PAC PORTABLE HEATING PAD". The FDA issued a decision of Substantially Equivalent on March 31, 1997. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1997
- Date Received
- September 26, 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