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FDA 510(k)

PULMANEX TM (MODIFICATION)

K-Number: K863026 · 1986-08-26

ApplicantLife Design Systems, Inc.
Decision Date1986-08-26
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMANEX TM (MODIFICATION) 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 1986-08-26 under 510(k) number K863026. 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 TM (MODIFICATION)?

PULMANEX TM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1986-08-26. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K863026.

When did PULMANEX TM (MODIFICATION) receive FDA 510(k) clearance?

PULMANEX TM (MODIFICATION) received FDA 510(k) clearance on 1986-08-26, under 510(k) number K863026.

Who is the listed applicant for PULMANEX TM (MODIFICATION)?

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 TM (MODIFICATION)?

The FDA product code for PULMANEX TM (MODIFICATION) 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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