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FDA 510(k)

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)

K-Number: K130068 · 2013-07-19

ApplicantEssex Industries, Inc. D/B/A Essex Cryogenics of M
Decision Date2013-07-19
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) is the device name listed in this FDA 510(k) record. The listed applicant is Essex Industries, Inc. D/B/A Essex Cryogenics of M. It received FDA 510(k) clearance on 2013-07-19 under 510(k) number K130068. 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 DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)?

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Essex Industries, Inc. D/B/A Essex Cryogenics of M. The 510(k) number is K130068.

When did DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) receive FDA 510(k) clearance?

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) received FDA 510(k) clearance on 2013-07-19, under 510(k) number K130068.

Who is the listed applicant for DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)?

The FDA 510(k) record lists Essex Industries, Inc. D/B/A Essex Cryogenics of M as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)?

The FDA product code for DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) 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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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.

K113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION 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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