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FDA 510(k)

LSPI INFANT BAG MASK

K-Number: K921553 · 1992-10-19

ApplicantLife Support Products, Inc.
Decision Date1992-10-19
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LSPI INFANT BAG MASK is the device name listed in this FDA 510(k) record. The listed applicant is Life Support Products, Inc.. It received FDA 510(k) clearance on 1992-10-19 under 510(k) number K921553. 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 LSPI INFANT BAG MASK?

LSPI INFANT BAG MASK is a medical device that received FDA 510(k) clearance on 1992-10-19. The listed applicant is Life Support Products, Inc.. The 510(k) number is K921553.

When did LSPI INFANT BAG MASK receive FDA 510(k) clearance?

LSPI INFANT BAG MASK received FDA 510(k) clearance on 1992-10-19, under 510(k) number K921553.

Who is the listed applicant for LSPI INFANT BAG MASK?

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

What is the FDA product code for LSPI INFANT BAG MASK?

The FDA product code for LSPI INFANT BAG MASK is BTM.

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Other records listing Life Support 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.

K941870LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100K941871LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100K940934LIFE VACK936187LSPI PRESSURE REGULATORK922691LSP (MODEL 554) BAG MASK RESUSCITATORK932199LSPI AUTOMATIC VENTILATOR, MODEL AV3000

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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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