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FDA 510(k)

PRECISION LIQUID OXYGEN SYSTEM

K-Number: K103324 · 2011-04-21

ApplicantPrecision Medical, Inc.
Decision Date2011-04-21
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRECISION LIQUID OXYGEN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical, Inc.. It received FDA 510(k) clearance on 2011-04-21 under 510(k) number K103324. 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 PRECISION LIQUID OXYGEN SYSTEM?

PRECISION LIQUID OXYGEN SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-21. The listed applicant is Precision Medical, Inc.. The 510(k) number is K103324.

When did PRECISION LIQUID OXYGEN SYSTEM receive FDA 510(k) clearance?

PRECISION LIQUID OXYGEN SYSTEM received FDA 510(k) clearance on 2011-04-21, under 510(k) number K103324.

Who is the listed applicant for PRECISION LIQUID OXYGEN SYSTEM?

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

What is the FDA product code for PRECISION LIQUID OXYGEN SYSTEM?

The FDA product code for PRECISION LIQUID OXYGEN SYSTEM is BYJ.

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Other records listing Precision Medical, 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.

K173807Accu O2 Oxygen AnalyzerK103563PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150K090781HELIO2 BLENDERK072348PRECISION OXYGEN CONCENTRATORK063096PRECISION OXYGEN MONITORK053232PRECISION BLENDER

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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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, 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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