Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SEALFLEX MASK

K-Number: K874746 · 1987-12-21

ApplicantEngineered Medical Systems
Decision Date1987-12-21
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SEALFLEX 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 1987-12-21 under 510(k) number K874746. 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 SEALFLEX MASK?

SEALFLEX MASK is a medical device that received FDA 510(k) clearance on 1987-12-21. The listed applicant is Engineered Medical Systems. The 510(k) number is K874746.

When did SEALFLEX MASK receive FDA 510(k) clearance?

SEALFLEX MASK received FDA 510(k) clearance on 1987-12-21, under 510(k) number K874746.

Who is the listed applicant for SEALFLEX 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 SEALFLEX MASK?

The FDA product code for SEALFLEX 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 22 devices →

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.

↑