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FDA 510(k)

MANUAL RESUSCITATION SYSTEM

K-Number: K840935 · 1984-04-05

ApplicantInspiron Corp.
Decision Date1984-04-05
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MANUAL RESUSCITATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inspiron Corp.. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840935. 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 MANUAL RESUSCITATION SYSTEM?

MANUAL RESUSCITATION SYSTEM is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Inspiron Corp.. The 510(k) number is K840935.

When did MANUAL RESUSCITATION SYSTEM receive FDA 510(k) clearance?

MANUAL RESUSCITATION SYSTEM received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840935.

Who is the listed applicant for MANUAL RESUSCITATION SYSTEM?

The FDA 510(k) record lists Inspiron Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL RESUSCITATION SYSTEM?

The FDA product code for MANUAL RESUSCITATION SYSTEM is BTM.

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Other records listing Inspiron Corp. 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.

K860838INSPIRON DOUBLE SWIVEL TRACH ADAPTERK850346OXYGEN CONCENTRATORK843932VAPOR-PHASE HUMIDIFIER SYS-ADVANCEDK841158NEBULO 28 NEBULIZER KITK840418INSPIRATORY/EXPIRATORY MUSCLE EXERCISK834290INSPIRON LIQUID OXYGEN SYSTEM

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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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