510(k) K821524

CHIROPRATIC INFRA-RED CRYSTAL PAK by Dr. John D. Reid B.A., D.C. — Product Code KYA

K821524 is an FDA 510(k) premarket notification submitted by Dr. John D. Reid B.A., D.C. for the device "CHIROPRATIC INFRA-RED CRYSTAL PAK". The FDA issued a decision of Substantially Equivalent on September 8, 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. Dr. John D. Reid B.A., D.C. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1982
Date Received
May 21, 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