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510(k) K850761

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

K850761 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Medicor USA , Ltd.

  • K861994 — MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM (July 18, 1986)
  • K861995 — MODEL RS-3 RADIOGRAPHIC STAND (June 19, 1986)
  • K860025 — MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR (May 7, 1986)
  • K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER (July 1, 1985)
  • K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER (June 19, 1985)
  • K843335 — FLOOR MOUNTED X-RAY TUBESTAND (November 27, 1984)
  • 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

  • K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (November 25, 1992)
  • K872558 — CART, EMERGENCY, CARDIOPULMONARY (July 24, 1987)
  • 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)

FDA data resources