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FDA 510(k)

MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3

K-Number: K101272 · 2010-08-20

ApplicantEssex Industries, Inc.
Decision Date2010-08-20
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 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 2010-08-20 under 510(k) number K101272. 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 MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3?

MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 is a medical device that received FDA 510(k) clearance on 2010-08-20. The listed applicant is Essex Industries, Inc.. The 510(k) number is K101272.

When did MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 receive FDA 510(k) clearance?

MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 received FDA 510(k) clearance on 2010-08-20, under 510(k) number K101272.

Who is the listed applicant for MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3?

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 MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3?

The FDA product code for MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 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-BoutK113767MOUNTED MEDICAL OXYGEN SYSTEM

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 MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, Inc.K072723RESPIRONICS GOLOXRespironics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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