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FDA 510(k)

ANESTHESIA/RESPIRATORY DISPOSABLE MASK

K-Number: K891316 · 1989-08-21

ApplicantConcord/Portex
Decision Date1989-08-21
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANESTHESIA/RESPIRATORY DISPOSABLE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K891316. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANESTHESIA/RESPIRATORY DISPOSABLE MASK?

ANESTHESIA/RESPIRATORY DISPOSABLE MASK is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Concord/Portex. The 510(k) number is K891316.

When did ANESTHESIA/RESPIRATORY DISPOSABLE MASK receive FDA 510(k) clearance?

ANESTHESIA/RESPIRATORY DISPOSABLE MASK received FDA 510(k) clearance on 1989-08-21, under 510(k) number K891316.

Who is the listed applicant for ANESTHESIA/RESPIRATORY DISPOSABLE MASK?

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

What is the FDA product code for ANESTHESIA/RESPIRATORY DISPOSABLE MASK?

The FDA product code for ANESTHESIA/RESPIRATORY DISPOSABLE MASK is BSJ.

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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.

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Other records listing Concord/Portex 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.

K923559STERI-CATH MDIK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK924541EPIDURAL MINIPACKK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSER

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Related Devices (Code: BSJ)

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.

K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing ConceptsK953295ANESTHESIA FACE MASKMallinckrodt MedicalK952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKOwens-Brigam Medical Co.K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, Inc.

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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