510(k) K823245
K823245 is an FDA 510(k) premarket notification submitted by American Thermometer Company, Inc. for the device "THERMAX; THERMAX SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 1982. The device falls under product code KYA (System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2982. American Thermometer Company, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1982
- Date Received
- November 1, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type