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FDA 510(k)

PULMONARY RESUSCITATOR, MODIFICATION

K-Number: K892221 · 1989-05-18

ApplicantLife Design Systems, Inc.
Decision Date1989-05-18
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMONARY RESUSCITATOR, 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 1989-05-18 under 510(k) number K892221. 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 PULMONARY RESUSCITATOR, MODIFICATION?

PULMONARY RESUSCITATOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1989-05-18. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K892221.

When did PULMONARY RESUSCITATOR, MODIFICATION receive FDA 510(k) clearance?

PULMONARY RESUSCITATOR, MODIFICATION received FDA 510(k) clearance on 1989-05-18, under 510(k) number K892221.

Who is the listed applicant for PULMONARY RESUSCITATOR, 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 PULMONARY RESUSCITATOR, MODIFICATION?

The FDA product code for PULMONARY RESUSCITATOR, 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 PERCUSSORK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBINGK890108MODIFIED CUSHION-FLEX(TM)

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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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