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510(k) K841090

VENTILATOR EXTERNAL BODY NEGATIVE PRESS by Porta-Lung Co. — Product Code BYT

K841090 is an FDA 510(k) premarket notification submitted by Porta-Lung Co. for the device "VENTILATOR EXTERNAL BODY NEGATIVE PRESS". The FDA issued a decision of Substantially Equivalent on May 30, 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
May 30, 1984
Date Received
March 13, 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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  • 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