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510(k) K811260

BARALYME CO2 ABSORBENT by Allied Healthcare Products, Inc. — Product Code CBL

K811260 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "BARALYME CO2 ABSORBENT". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code CBL (Absorbent, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5300. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1981
Date Received
May 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbent, Carbon-Dioxide
Device Class
Class I
Regulation Number
868.5300
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 CBL

  • K921803 — SOFNOLIME CARBON DIOXIDE ABSORBENT (October 15, 1992)
  • K897171 — DISPOSABLE CO2 ABSORBER/E (March 13, 1990)
  • K860147 — CARBON DIOXIDE ABSORBENTS (February 28, 1986)
  • K853571 — MEDIPART SODA LIME MP-3522 (October 29, 1985)

FDA data resources