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FDA 510(k)

AMBU OXYGEN REGULATOR

K-Number: K921125 · 1992-09-17

ApplicantAmg, LLC
Decision Date1992-09-17
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 Amg, LLC. It received FDA 510(k) clearance on 1992-09-17 under 510(k) number K921125. 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 1992-09-17. The listed applicant is Amg, LLC. The 510(k) number is K921125.

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

AMBU OXYGEN REGULATOR received FDA 510(k) clearance on 1992-09-17, under 510(k) number K921125.

Who is the listed applicant for AMBU OXYGEN REGULATOR?

The FDA 510(k) record lists Amg, LLC 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.

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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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