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510(k) K840885

LAKEVILLE BODY VENTILATOR by Edwards Ventilator Co. — Product Code BYT

K840885 is an FDA 510(k) premarket notification submitted by Edwards Ventilator Co. for the device "LAKEVILLE BODY VENTILATOR". The FDA issued a decision of Substantially Equivalent on July 12, 1984. 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
July 12, 1984
Date Received
February 27, 1984
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

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  • 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)
  • K903745 — THE HAYEK OSCILLATOR (November 9, 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)

FDA data resources