510(k) K072534
K072534 is an FDA 510(k) premarket notification submitted by Richway Intl., Inc. for the device "BIO-MAT 2000". The FDA issued a decision of Substantially Equivalent on February 8, 2008. 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
- February 8, 2008
- Date Received
- September 7, 2007
- 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