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FDA 510(k)

PROTEGE LIQUID OXYGEN SYSTEM

K-Number: K971545 · 1997-07-25

ApplicantHealthdyne Technologies, Inc.
Decision Date1997-07-25
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PROTEGE LIQUID OXYGEN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Technologies, Inc.. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K971545. 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 PROTEGE LIQUID OXYGEN SYSTEM?

PROTEGE LIQUID OXYGEN SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Healthdyne Technologies, Inc.. The 510(k) number is K971545.

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

PROTEGE LIQUID OXYGEN SYSTEM received FDA 510(k) clearance on 1997-07-25, under 510(k) number K971545.

Who is the listed applicant for PROTEGE LIQUID OXYGEN SYSTEM?

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

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

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

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Other records listing Healthdyne Technologies, 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.

K983572SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500K974453NASAL INTERFACE MODEL 7910K974879MODEL 7410 VOYAGERK972614TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605K971867ALICE 4R SYSTEMK970173MODEL 1700 TRANQUILITY BILEVEL SYSTEM

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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.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, 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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