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FDA 510(k)

PULMANEX

K-Number: K854037 · 1985-11-01

ApplicantLife Design Systems, Inc.
Decision Date1985-11-01
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMANEX is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K854037. 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 PULMANEX?

PULMANEX is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K854037.

When did PULMANEX receive FDA 510(k) clearance?

PULMANEX received FDA 510(k) clearance on 1985-11-01, under 510(k) number K854037.

Who is the listed applicant for PULMANEX?

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

What is the FDA product code for PULMANEX?

The FDA product code for PULMANEX is BTM.

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Other records listing Life Design Systems, 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.

K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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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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