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510(k) K082657

RTX RESPIRATOR by Medivent Limited — Product Code BYT

K082657 is an FDA 510(k) premarket notification submitted by Medivent Limited for the device "RTX RESPIRATOR". The FDA issued a decision of Substantially Equivalent on October 8, 2008. 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
October 8, 2008
Date Received
September 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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

  • 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)
  • 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)
  • K893213 — EASY BREATHER MODEL 100 (August 4, 1989)

FDA data resources