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FDA 510(k)

RIBBED CUSHION MASK

K-Number: K871851 · 1987-06-08

ApplicantEngineered Medical Systems
Decision Date1987-06-08
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RIBBED CUSHION MASK is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 1987-06-08 under 510(k) number K871851. 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 RIBBED CUSHION MASK?

RIBBED CUSHION MASK is a medical device that received FDA 510(k) clearance on 1987-06-08. The listed applicant is Engineered Medical Systems. The 510(k) number is K871851.

When did RIBBED CUSHION MASK receive FDA 510(k) clearance?

RIBBED CUSHION MASK received FDA 510(k) clearance on 1987-06-08, under 510(k) number K871851.

Who is the listed applicant for RIBBED CUSHION MASK?

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

What is the FDA product code for RIBBED CUSHION MASK?

The FDA product code for RIBBED CUSHION 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 Engineered Medical Systems 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.

K023683MULTI-STRAP FULL FACE MASKK013728TRACH VOXK013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONK013089EMS HEPA FILTER AND HME COMBINATIONSK013123EMS PULMONARY FUNCTION TESTING FILTERK003497DISPOSABLE PRESSURE MONITOR

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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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