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FDA 510(k)

MOUTH TO MASK RESUSCITATOR

K-Number: K912625 · 1991-08-02

ApplicantVital Signs, Inc.
Decision Date1991-08-02
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTH TO MASK RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1991-08-02 under 510(k) number K912625. 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 MOUTH TO MASK RESUSCITATOR?

MOUTH TO MASK RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is Vital Signs, Inc.. The 510(k) number is K912625.

When did MOUTH TO MASK RESUSCITATOR receive FDA 510(k) clearance?

MOUTH TO MASK RESUSCITATOR received FDA 510(k) clearance on 1991-08-02, under 510(k) number K912625.

Who is the listed applicant for MOUTH TO MASK RESUSCITATOR?

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

What is the FDA product code for MOUTH TO MASK RESUSCITATOR?

The FDA product code for MOUTH TO MASK RESUSCITATOR is BTM.

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Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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