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510(k) K920196

OX-600 by Stardard X-Ray Sales Co. — Product Code KPX

K920196 is an FDA 510(k) premarket notification submitted by Stardard X-Ray Sales Co. for the device "OX-600". The FDA issued a decision of Substantially Equivalent on October 14, 1992. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1992
Date Received
January 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
Review Panel
RA
Submission Type

Other clearances for product code KPX

  • K945635 — TRANS X-1000 (February 1, 1995)
  • K935157 — ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES (August 9, 1994)
  • K934850 — NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS (November 22, 1993)
  • K933035 — BCM-600TX (October 8, 1993)
  • K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (February 1, 1993)
  • K924423 — MWX-7440 HIGH SPEED BUCKY (January 15, 1993)
  • K925169 — SHIMADZU RADIOGRAPJHIC STAND BR-100 (December 3, 1992)
  • K922483 — DU PONT COMPACT DAYLIGHT SYSTEM 2000 (September 11, 1992)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K902761 — AUTOMATIC CASSETTE LOADER (October 9, 1990)

FDA data resources