510(k) K022737

HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC by Health Care Mfg., Inc. — Product Code KPR

K022737 is an FDA 510(k) premarket notification submitted by Health Care Mfg., Inc. for the device "HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC". The FDA issued a decision of Substantially Equivalent on October 22, 2002. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Health Care Mfg., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2002
Date Received
August 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type