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510(k) K935157

ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES by Regulatory Consultants TO the Medical Device Indus — Product Code KPX

K935157 is an FDA 510(k) premarket notification submitted by Regulatory Consultants TO the Medical Device Indus for the device "ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES". The FDA issued a decision of Substantially Equivalent on August 9, 1994. 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
August 9, 1994
Date Received
October 28, 1993
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)
  • 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)
  • K920196 — OX-600 (October 14, 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