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FDA 510(k)

SUR-FIT FACE MASK

K-Number: K854161 · 1985-11-05

ApplicantAnesthesia Respiratory Technology, Inc.
Decision Date1985-11-05
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUR-FIT FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Anesthesia Respiratory Technology, Inc.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K854161. 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 SUR-FIT FACE MASK?

SUR-FIT FACE MASK is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Anesthesia Respiratory Technology, Inc.. The 510(k) number is K854161.

When did SUR-FIT FACE MASK receive FDA 510(k) clearance?

SUR-FIT FACE MASK received FDA 510(k) clearance on 1985-11-05, under 510(k) number K854161.

Who is the listed applicant for SUR-FIT FACE MASK?

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

What is the FDA product code for SUR-FIT FACE MASK?

The FDA product code for SUR-FIT FACE MASK is BSJ.

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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