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510(k) K903745

THE HAYEK OSCILLATOR by Flexco Medical Instruments — Product Code BYT

K903745 is an FDA 510(k) premarket notification submitted by Flexco Medical Instruments for the device "THE HAYEK OSCILLATOR". The FDA issued a decision of Substantially Equivalent on November 9, 1990. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1990
Date Received
August 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device Class
Class II
Regulation Number
868.5935
Review Panel
AN
Submission Type

Other clearances for product code BYT

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  • K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (May 29, 2008)
  • K924341 — HAYEK OSCILLATOR(TM) (July 21, 1993)
  • K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR (June 3, 1991)
  • K905530 — PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM (March 1, 1991)
  • K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (November 19, 1990)
  • K902300 — EASY BREATHER MODEL 100 ACCESSORIES (July 19, 1990)
  • K895849 — RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM (December 22, 1989)
  • K894649 — EMERSON 33-CR CHEST RESPIRATOR (October 13, 1989)
  • K893213 — EASY BREATHER MODEL 100 (August 4, 1989)

FDA data resources