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FDA 510(k)

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK

K-Number: K951043 · 1995-06-07

ApplicantPromedic, Inc.
Decision Date1995-06-07
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K951043. 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 AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK?

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Promedic, Inc.. The 510(k) number is K951043.

When did AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK receive FDA 510(k) clearance?

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK received FDA 510(k) clearance on 1995-06-07, under 510(k) number K951043.

Who is the listed applicant for AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK?

The FDA 510(k) record lists Promedic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK?

The FDA product code for AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK is BSJ.

Related Clinical Trials

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Other records listing Promedic, 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.

K112318CLEARPATH 24K072756NON-IV ADAPTER FOR INFANT NG TUBEK060497BABYAIRK060842REVJET TURBOK052903PEDIATRIC FEEDING TUBEK031409URINARY CATHETERS

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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.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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