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510(k) K810585

SARA by Allied Healthcare Products, Inc. — Product Code CBS

K810585 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "SARA". The FDA issued a decision of Substantially Equivalent on March 24, 1981. The device falls under product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1620. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1981
Date Received
March 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1620
Review Panel
AN
Submission Type

Other clearances by Allied Healthcare Products, Inc.

  • K131098 — EMERGENCY PORTABLE VENTILATOR (April 9, 2014)
  • K132021 — AHP 300, EMERGENCY PORTABLE VENTILATOR (April 2, 2014)
  • K090356 — EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (May 20, 2009)
  • K083507 — BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (May 18, 2009)
  • K083385 — MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (May 14, 2009)
  • K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100 (August 15, 2008)
  • K072214 — PORTABLE VENTILATOR, MODEL EPV-100 (March 6, 2008)
  • K073171 — RESUSCITATION TIMER, MODEL L770-CPR (January 31, 2008)
  • K070636 — AUTOVENT 4000 WITH CPAP (July 13, 2007)
  • K070120 — AUTOVENT MODEL 4000 (May 3, 2007)

Other clearances for product code CBS

  • K974903 — GAS MODULE II, MODEL 0998-00-0143 (March 13, 1998)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV (May 3, 1996)
  • K951366 — RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (August 2, 1995)
  • K950101 — RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (March 21, 1995)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K942737 — POET IQ WITH FIVE AGENT CAPABILITY (February 9, 1995)
  • K932389 — 8100 ANESTHETIC AGENT MONITOR (December 3, 1993)
  • K905754 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (June 17, 1991)
  • K896629 — NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (February 12, 1990)

FDA data resources