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FDA 510(k)

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK

K-Number: K952689 · 1995-07-11

ApplicantOwens-Brigam Medical Co.
Decision Date1995-07-11
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Owens-Brigam Medical Co.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K952689. 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 BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK?

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Owens-Brigam Medical Co.. The 510(k) number is K952689.

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

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK received FDA 510(k) clearance on 1995-07-11, under 510(k) number K952689.

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

The FDA 510(k) record lists Owens-Brigam Medical Co. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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 Owens-Brigam Medical Co. 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.

K963848MANUAL RESUSCITATOR

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 MedicalK951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, Inc.K945894MASK, GAS, ANESTHETICHans Rudolph, 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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