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510(k) K813326

TROCKI BODY VENTRILATOR by L.T.D. 3 Co. — Product Code BYT

K813326 is an FDA 510(k) premarket notification submitted by L.T.D. 3 Co. for the device "TROCKI BODY VENTRILATOR". The FDA issued a decision of Substantially Equivalent on December 22, 1981. 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
December 22, 1981
Date Received
November 24, 1981
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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  • 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