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FDA 510(k)

LINDE MARK II

K-Number: K812536 · 1981-09-23

ApplicantUnion Carbide Corp.
Decision Date1981-09-23
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LINDE MARK II is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812536. 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 LINDE MARK II?

LINDE MARK II is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Union Carbide Corp.. The 510(k) number is K812536.

When did LINDE MARK II receive FDA 510(k) clearance?

LINDE MARK II received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812536.

Who is the listed applicant for LINDE MARK II?

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

What is the FDA product code for LINDE MARK II?

The FDA product code for LINDE MARK II is BYJ.

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Other records listing Union Carbide Corp. 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.

K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZERK810129CENTRIFICHEM SYSTEM 500

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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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