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510(k) K832176

NEGATIVE PRESSURE CHEST RESPIRATOR PUMP by J. H. Emerson Co. — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 6, 1983
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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  • K873489 — EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 (December 29, 1987)
  • K872937 — 97-TD EMERSON TIMER/DIMMER CONTROL (September 24, 1987)
  • K872936 — 97-D EMERSON DIMMER CONTROL (September 24, 1987)
  • K864379 — EMERSON 3MV VOLUME VENTILATOR (December 15, 1986)

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