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FDA 510(k)

AMBU OXYGEN REGULATOR

K-Number: K901623 · 1990-04-26

ApplicantFlotec, Inc.
Decision Date1990-04-26
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU OXYGEN REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Flotec, Inc.. It received FDA 510(k) clearance on 1990-04-26 under 510(k) number K901623. 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 AMBU OXYGEN REGULATOR?

AMBU OXYGEN REGULATOR is a medical device that received FDA 510(k) clearance on 1990-04-26. The listed applicant is Flotec, Inc.. The 510(k) number is K901623.

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

AMBU OXYGEN REGULATOR received FDA 510(k) clearance on 1990-04-26, under 510(k) number K901623.

Who is the listed applicant for AMBU OXYGEN REGULATOR?

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

What is the FDA product code for AMBU OXYGEN REGULATOR?

The FDA product code for AMBU OXYGEN 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 Flotec, 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.

K970371FLOTEC OXYSAVRR (S)

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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