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510(k) K820077

EMERSON THORACIC SUCTION REG. #55-JP by J. H. Emerson Co. — Product Code KDP

K820077 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON THORACIC SUCTION REG. #55-JP". The FDA issued a decision of Substantially Equivalent on January 28, 1982. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
January 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
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)
  • 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)

Other clearances for product code KDP

  • K013976 — BOEHRINGER MRI SUCTION REGULATORY (January 8, 2002)
  • K944479 — PM3300 INTERMITTENT VACUUM (December 22, 1994)
  • K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (July 21, 1994)
  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)

FDA data resources