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FDA 510(k)

OXYGEN THERAPY REGULATOR

K-Number: K894302 · 1989-08-07

ApplicantModern Engineering Co., Inc.
Decision Date1989-08-07
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN THERAPY REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Modern Engineering Co., Inc.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K894302. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN THERAPY REGULATOR?

OXYGEN THERAPY REGULATOR is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Modern Engineering Co., Inc.. The 510(k) number is K894302.

When did OXYGEN THERAPY REGULATOR receive FDA 510(k) clearance?

OXYGEN THERAPY REGULATOR received FDA 510(k) clearance on 1989-08-07, under 510(k) number K894302.

Who is the listed applicant for OXYGEN THERAPY REGULATOR?

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

What is the FDA product code for OXYGEN THERAPY REGULATOR?

The FDA product code for OXYGEN THERAPY REGULATOR is CAN.

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 Modern Engineering Co., 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.

K8948508053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI

Related Devices (Code: CAN)

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.

K162811MR Conditional CGA 870Essex Industries, Inc.K080243PORTABLE OXYGEN UNIT SCA900San Cheong Co. , Ltd.K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATORRemcore, Inc.K061785CYL-FIL OXYGEN SYSTEMResponsive Respiratory, Inc.K950777OXYGEN REGULATORMada Medical Products, Inc.K942751VANGUARD SERIES GAS REGULATORSBuckman Co., 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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