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FDA 510(k)

UNIT, LIQUID, OXYGEN, PORTABLE

K-Number: K813453 · 1982-01-12

ApplicantPensee Medical Corp.
Decision Date1982-01-12
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIT, LIQUID, OXYGEN, PORTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Pensee Medical Corp.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813453. 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 UNIT, LIQUID, OXYGEN, PORTABLE?

UNIT, LIQUID, OXYGEN, PORTABLE is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Pensee Medical Corp.. The 510(k) number is K813453.

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

UNIT, LIQUID, OXYGEN, PORTABLE received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813453.

Who is the listed applicant for UNIT, LIQUID, OXYGEN, PORTABLE?

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

What is the FDA product code for UNIT, LIQUID, OXYGEN, PORTABLE?

The FDA product code for UNIT, LIQUID, OXYGEN, PORTABLE is BYJ.

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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

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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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