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510(k) K854410

VERIFLEX by Old Delft Corp. of America — Product Code KPZ

K854410 is an FDA 510(k) premarket notification submitted by Old Delft Corp. of America for the device "VERIFLEX". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code KPZ (Generator, High Voltage, X-Ray, Therapeutic), 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
February 12, 1986
Date Received
November 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Old Delft Corp. of America

  • K862616 — AMBER-CHEST (September 2, 1986)
  • K861431 — THERAPAX HT 150T (May 21, 1986)

Other clearances for product code KPZ

  • K912249 — PATIENT DOSE MONITOR (August 30, 1991)
  • K860469 — 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS (April 16, 1986)

FDA data resources