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FDA 510(k)

NON-CONDUCTIVE, SINGLE USE FACE MASK #55

K-Number: K801251 · 1980-06-04

ApplicantVital Signs, Inc.
Decision Date1980-06-04
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NON-CONDUCTIVE, SINGLE USE FACE MASK #55 is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K801251. 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 NON-CONDUCTIVE, SINGLE USE FACE MASK #55?

NON-CONDUCTIVE, SINGLE USE FACE MASK #55 is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Vital Signs, Inc.. The 510(k) number is K801251.

When did NON-CONDUCTIVE, SINGLE USE FACE MASK #55 receive FDA 510(k) clearance?

NON-CONDUCTIVE, SINGLE USE FACE MASK #55 received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801251.

Who is the listed applicant for NON-CONDUCTIVE, SINGLE USE FACE MASK #55?

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

What is the FDA product code for NON-CONDUCTIVE, SINGLE USE FACE MASK #55?

The FDA product code for NON-CONDUCTIVE, SINGLE USE FACE MASK #55 is BSJ.

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Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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