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FDA 510(k)

PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)

K-Number: K863978 · 1986-12-15

ApplicantPenox Technologies, Inc.
Decision Date1986-12-15
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Penox Technologies, Inc.. It received FDA 510(k) clearance on 1986-12-15 under 510(k) number K863978. 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 PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)?

PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Penox Technologies, Inc.. The 510(k) number is K863978.

When did PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) receive FDA 510(k) clearance?

PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) received FDA 510(k) clearance on 1986-12-15, under 510(k) number K863978.

Who is the listed applicant for PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)?

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

What is the FDA product code for PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)?

The FDA product code for PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) 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 Penox 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.

K864667PENOX HOSPITAL BEDK862654MODIFIED PENOX LIFT CHAIRK853775PENOX HIGH FLOW MANIFOLDK852109PENOX PERFORMER WHEELCHAIRK851218PENOX LIFT CHAIRK851217PENOX DUAL FLOW MINIFOLD

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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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