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510(k) K902764

EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM by J. H. Emerson Co. — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1990
Date Received
June 25, 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 by J. H. Emerson Co.

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  • K920910 — OXYGEN POWERED RESUSCITATOR FOR CPR (January 12, 1993)
  • K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA (November 17, 1992)
  • K896721 — MODEL 7-AT TREATMENT CHAMBER (January 22, 1990)
  • K881808 — EMERSON CHEST RESPIRATOR, MODEL 33-CRE (August 4, 1988)
  • K873489 — EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 (December 29, 1987)
  • K872936 — 97-D EMERSON DIMMER CONTROL (September 24, 1987)
  • K872937 — 97-TD EMERSON TIMER/DIMMER CONTROL (September 24, 1987)
  • K864379 — EMERSON 3MV VOLUME VENTILATOR (December 15, 1986)
  • K864394 — EMERSON 3MV VOLUME VENTILATOR (December 5, 1986)

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  • K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR (June 3, 1991)
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  • 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)