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510(k) K802231

AIR VIVA II by General Medical Co. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by General Medical Co.

  • K926269 — PROCEDURE KIT (August 27, 1993)
  • K912975 — OPERAND LUBRICATING JELLY (September 27, 1991)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K903669 — GENESIS INSUFFLATING CATHETER (September 12, 1990)
  • K900110 — OPERAND* LUBRICATING JELLY (May 2, 1990)
  • K853635 — SUBDERM TM (December 20, 1985)
  • K844652 — C.A.S.E. CONTAINER (December 12, 1984)
  • K831320 — DRIONIC (July 19, 1983)
  • K820689 — C.S.R. WRAPPERS (April 9, 1982)
  • K820521 — STERILIZATION WRAP (March 18, 1982)

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  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)