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510(k) K881207

RES-Q 1, 2, 3, 4 AND 5 by Nova-Ventrx — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1988
Date Received
March 21, 1988
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 Nova-Ventrx

  • K952267 — CRITERION, CRITERION I.V., MODIFIED (December 2, 1997)
  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K893760 — CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 (August 10, 1989)
  • K870382 — DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 (March 6, 1987)
  • K863756 — MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (November 13, 1986)
  • K850600 — CO-AX VENTILATOR CIRCUIT (May 2, 1985)
  • K842795 — MAXI-MISER HUMIDIFIER INSERT 1030 (October 4, 1984)
  • K842794 — MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 (October 4, 1984)
  • K841571 — MAXI-MISER WATER TRANSFER SET 1021/1022 (May 30, 1984)
  • K841569 — MAXI-MISER HUMIDIFIER INSERT 1020 (May 30, 1984)

Other clearances for product code BTM

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  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K212905 — Sotair Device (August 18, 2022)
  • 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)