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FDA 510(k)

SERIES 2000 MEDS MASK

K-Number: K853785 · 1985-12-03

ApplicantMed Systems
Decision Date1985-12-03
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SERIES 2000 MEDS MASK is the device name listed in this FDA 510(k) record. The listed applicant is Med Systems. It received FDA 510(k) clearance on 1985-12-03 under 510(k) number K853785. 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 SERIES 2000 MEDS MASK?

SERIES 2000 MEDS MASK is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is Med Systems. The 510(k) number is K853785.

When did SERIES 2000 MEDS MASK receive FDA 510(k) clearance?

SERIES 2000 MEDS MASK received FDA 510(k) clearance on 1985-12-03, under 510(k) number K853785.

Who is the listed applicant for SERIES 2000 MEDS MASK?

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

What is the FDA product code for SERIES 2000 MEDS MASK?

The FDA product code for SERIES 2000 MEDS 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 Med 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.

K031876ELECTRO FLO PERCUSSOR, MODEL 5000K941145OXY-GENERATOR

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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