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510(k) K940539

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM by Standard Imaging, Inc. — Product Code KPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
February 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

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  • K922554 — STANDARD IMAGING HDR 1000 ION CHAMBER (August 24, 1992)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K953610 — AUKULYTE (September 26, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)
  • K912327 — DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. (March 18, 1992)