510(k) K843124
K843124 is an FDA 510(k) premarket notification submitted by Qmax Medical, Inc. for the device "Q-SCAN THERMOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 1984. The device falls under product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)), a Class III device regulated under 21 CFR 884.2982.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1984
- Date Received
- August 8, 1984
- 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