510(k) K851034
K851034 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "NOVATHERM". The FDA issued a decision of Substantially Equivalent on September 27, 1985. The device falls under product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)), a Class III device regulated under 21 CFR 884.2982. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1985
- Date Received
- March 13, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
- Device Class
- Class III
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type