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FDA 510(k)

PREMIUM DABM DISPOS. ANES. BREATH MASK

K-Number: K840452 · 1984-02-17

ApplicantOhio Medical Products
Decision Date1984-02-17
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREMIUM DABM DISPOS. ANES. BREATH MASK is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Products. It received FDA 510(k) clearance on 1984-02-17 under 510(k) number K840452. 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 PREMIUM DABM DISPOS. ANES. BREATH MASK?

PREMIUM DABM DISPOS. ANES. BREATH MASK is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Ohio Medical Products. The 510(k) number is K840452.

When did PREMIUM DABM DISPOS. ANES. BREATH MASK receive FDA 510(k) clearance?

PREMIUM DABM DISPOS. ANES. BREATH MASK received FDA 510(k) clearance on 1984-02-17, under 510(k) number K840452.

Who is the listed applicant for PREMIUM DABM DISPOS. ANES. BREATH MASK?

The FDA 510(k) record lists Ohio Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIUM DABM DISPOS. ANES. BREATH MASK?

The FDA product code for PREMIUM DABM DISPOS. ANES. BREATH MASK is BSJ.

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Other records listing Ohio Medical Products 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.

K841733OHIO WASTE GAS SCAVENGING RESERVOIRK842003OHIO WASTE GAS SCAVENGING INTERFACEK840356OHIO UNITROL II ANESTHESIA GAS MACHINEK841274BAG-TO-VENTILATOR SELECTOR VALVEK840967OHIO HEAT REFLECTING PATCHK840857OHIO 3000 INFANT WARMER SYSTEM

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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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