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FDA 510(k)

LIFE-MASK INFANT RESUSCITATOR

K-Number: K842696 · 1984-07-27

ApplicantElectronic Monitors, Inc.
Decision Date1984-07-27
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFE-MASK INFANT RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Monitors, Inc.. It received FDA 510(k) clearance on 1984-07-27 under 510(k) number K842696. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE-MASK INFANT RESUSCITATOR?

LIFE-MASK INFANT RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1984-07-27. The listed applicant is Electronic Monitors, Inc.. The 510(k) number is K842696.

When did LIFE-MASK INFANT RESUSCITATOR receive FDA 510(k) clearance?

LIFE-MASK INFANT RESUSCITATOR received FDA 510(k) clearance on 1984-07-27, under 510(k) number K842696.

Who is the listed applicant for LIFE-MASK INFANT RESUSCITATOR?

The FDA 510(k) record lists Electronic Monitors, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFE-MASK INFANT RESUSCITATOR?

The FDA product code for LIFE-MASK INFANT RESUSCITATOR is BTM.

Related Clinical Trials

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Other records listing Electronic Monitors, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922393EMITENS ELECTRODESK822319RE1000 HEART RATE MONITOR

Related Devices (Code: BTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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