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510(k) K850761

MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C by Medicor USA , Ltd. — Product Code BZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1985
Date Received
February 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device Class
Class I
Regulation Number
868.6175
Review Panel
AN
Submission Type

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  • K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER (June 19, 1985)
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  • K840227 — UROLIX-3 UROLOGICAL TABLE (March 23, 1984)
  • K840225 — C-ARM CEILING CRANE FT-2 (March 22, 1984)
  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)
  • K823695 — CPM METABOLIC MONITOR (January 14, 1983)

Other clearances for product code BZN

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  • K840264 — SERVO CART 170 (February 4, 1984)
  • K832697 — RMP INTUBATION EQUIP. STORAGE TRAY (December 27, 1983)
  • K832356 — PORTABLE OPERAT. RM. MONITORS HS30/40 (October 28, 1983)
  • K832355 — CRASH CART (October 28, 1983)
  • K772320 — EMERGENCY CART (January 3, 1978)