510(k) K861431

THERAPAX HT 150T by Old Delft Corp. of America — Product Code JAD

K861431 is an FDA 510(k) premarket notification submitted by Old Delft Corp. of America for the device "THERAPAX HT 150T". The FDA issued a decision of Substantially Equivalent on May 21, 1986. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Old Delft Corp. of America has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1986
Date Received
April 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type