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510(k) K842911

PUCK U & UD CUTFILM CHANGERS by Elema-Schonander, Inc. — Product Code KPX

K842911 is an FDA 510(k) premarket notification submitted by Elema-Schonander, Inc. for the device "PUCK U & UD CUTFILM CHANGERS". The FDA issued a decision of Substantially Equivalent on August 21, 1984. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Elema-Schonander, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1984
Date Received
July 23, 1984
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 by Elema-Schonander, Inc.

  • K934944 — MPQ-42 (December 15, 1993)
  • K904103 — SEP 90 (November 20, 1990)
  • K903576 — PUCK 90M (September 4, 1990)
  • K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (August 21, 1984)
  • K840389 — SEP PROGRAMMER SEP-M/SINGLE-PLANE & (February 21, 1984)
  • K790792 — PULSE GENERATOR MODEL 637 (October 12, 1979)
  • K790670 — PULSE GENERATOR MODEL 629 (June 27, 1979)
  • K781178 — PULSE GENERATOR MODEL 208 (September 7, 1978)
  • K770005 — PACEMAKER 208S (February 24, 1977)
  • K770135 — LEAD MODIFICATION (February 7, 1977)

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)
  • K920196 — OX-600 (October 14, 1992)
  • K922483 — DU PONT COMPACT DAYLIGHT SYSTEM 2000 (September 11, 1992)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)

FDA data resources