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510(k) K896721

MODEL 7-AT TREATMENT CHAMBER by J. H. Emerson Co. — Product Code LGM

K896721 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "MODEL 7-AT TREATMENT CHAMBER". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
November 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Patient Isolation
Device Class
Class II
Regulation Number
880.5450
Review Panel
HO
Submission Type

Other clearances by J. H. Emerson Co.

  • K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL (November 22, 2000)
  • K920910 — OXYGEN POWERED RESUSCITATOR FOR CPR (January 12, 1993)
  • K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA (November 17, 1992)
  • K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (November 19, 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)

Other clearances for product code LGM

  • K231256 — Carecube Negative Pressure Isolation Chamber (January 3, 2024)
  • K163223 — ORCA (tm) - Operational Rescue Containment Apparatus (November 2, 2017)
  • K080117 — PATIENT ISOLATION UNIT, MODEL G019-1000 (January 30, 2009)
  • K022260 — FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS (August 29, 2002)
  • K944133 — MTB 1043 TREATMENT BOOTH (September 7, 1995)
  • K912444 — MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (February 18, 1992)
  • K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE (November 8, 1988)
  • K874306 — INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE (March 22, 1988)
  • K864116 — ANAGO ISOLATION MASK (#80-950) (November 25, 1986)
  • K831062 — ISOLATION MASK I.C.S. (April 13, 1983)

FDA data resources