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510(k) K170663

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer by Foremount Enterprise Co., Ltd. — Product Code BTM

K170663 is an FDA 510(k) premarket notification submitted by Foremount Enterprise Co., Ltd. for the device "Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer". The FDA issued a decision of Substantially Equivalent on May 11, 2018. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2018
Date Received
March 6, 2017
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

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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)
  • 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)
  • K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (January 28, 2011)

FDA data resources