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FDA 510(k)

MOUNTED MEDICAL OXYGEN SYSTEM

K-Number: K113767 · 2012-06-29

ApplicantEssex Industries, Inc.
Decision Date2012-06-29
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUNTED MEDICAL OXYGEN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Essex Industries, Inc.. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K113767. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUNTED MEDICAL OXYGEN SYSTEM?

MOUNTED MEDICAL OXYGEN SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Essex Industries, Inc.. The 510(k) number is K113767.

When did MOUNTED MEDICAL OXYGEN SYSTEM receive FDA 510(k) clearance?

MOUNTED MEDICAL OXYGEN SYSTEM received FDA 510(k) clearance on 2012-06-29, under 510(k) number K113767.

Who is the listed applicant for MOUNTED MEDICAL OXYGEN SYSTEM?

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

What is the FDA product code for MOUNTED MEDICAL OXYGEN SYSTEM?

The FDA product code for MOUNTED MEDICAL OXYGEN SYSTEM is BYJ.

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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Other records listing Essex Industries, 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.

K162811MR Conditional CGA 870K161472Walk-O2-BoutK101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3

Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, Inc.K072723RESPIRONICS GOLOXRespironics, 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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