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FDA 510(k)

LIFEGUARD MOUTH TO MASK RESUSCITATOR

K-Number: K881086 · 1988-04-14

ApplicantLifeguard Medical Products, Inc.
Decision Date1988-04-14
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFEGUARD MOUTH TO MASK RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lifeguard Medical Products, Inc.. It received FDA 510(k) clearance on 1988-04-14 under 510(k) number K881086. 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 LIFEGUARD MOUTH TO MASK RESUSCITATOR?

LIFEGUARD MOUTH TO MASK RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is Lifeguard Medical Products, Inc.. The 510(k) number is K881086.

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

LIFEGUARD MOUTH TO MASK RESUSCITATOR received FDA 510(k) clearance on 1988-04-14, under 510(k) number K881086.

Who is the listed applicant for LIFEGUARD MOUTH TO MASK RESUSCITATOR?

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

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

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

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Other records listing Lifeguard Medical Products, 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.

K013421LIFEGUARD NASAL CPAP MASK AND ACCESSORIESK915296MONOPOLAR ELECTRODEK920471LEVY ARTICULATING RETRACTORK915505REGULATOR FLOWMETERK915297TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MMK915298SUCTION/IRRIGATION CANNULA; CATLOG #532.00

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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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