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510(k) K941547

CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT by Allied Healthcare Products, Inc. — Product Code BYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
March 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tent, Oxygen, Electrically Powered
Device Class
Class II
Regulation Number
868.5710
Review Panel
AN
Submission Type

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  • K083385 — MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (May 14, 2009)
  • K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100 (August 15, 2008)
  • K072214 — PORTABLE VENTILATOR, MODEL EPV-100 (March 6, 2008)
  • K073171 — RESUSCITATION TIMER, MODEL L770-CPR (January 31, 2008)
  • K070636 — AUTOVENT 4000 WITH CPAP (July 13, 2007)
  • K070120 — AUTOVENT MODEL 4000 (May 3, 2007)

Other clearances for product code BYK

  • K882817 — LUNG DIFFUSION GAS MIXTURE (August 15, 1988)
  • K813235 — DISS FEMALE AIR ADAPTOR (December 8, 1981)