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FDA 510(k)

MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR

K-Number: K903443 · 1990-08-17

ApplicantPuritan Bennett Corp.
Decision Date1990-08-17
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K903443. 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 MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR?

MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K903443.

When did MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR receive FDA 510(k) clearance?

MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR received FDA 510(k) clearance on 1990-08-17, under 510(k) number K903443.

Who is the listed applicant for MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR?

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

What is the FDA product code for MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR?

The FDA product code for MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR is BTM.

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Other records listing Puritan Bennett 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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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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