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FDA 510(k)

AVL MODEL 912 CO-OXYLITE

K-Number: K895466 · 1989-11-06

ApplicantAvl Scientific Corp.
Decision Date1989-11-06
Product CodeGLY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVL MODEL 912 CO-OXYLITE is the device name listed in this FDA 510(k) record. The listed applicant is Avl Scientific Corp.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K895466. The device is classified under product code GLY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVL MODEL 912 CO-OXYLITE?

AVL MODEL 912 CO-OXYLITE is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Avl Scientific Corp.. The 510(k) number is K895466.

When did AVL MODEL 912 CO-OXYLITE receive FDA 510(k) clearance?

AVL MODEL 912 CO-OXYLITE received FDA 510(k) clearance on 1989-11-06, under 510(k) number K895466.

Who is the listed applicant for AVL MODEL 912 CO-OXYLITE?

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

What is the FDA product code for AVL MODEL 912 CO-OXYLITE?

The FDA product code for AVL MODEL 912 CO-OXYLITE is GLY.

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Other records listing Avl Scientific 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.

K001632OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009K000103AVL OPTI R ANALYZERK993837AVL OPTI CRITICAL CARE ANALYZERK990092AVL OMNI MODULAR ANALYZERK984299AVL OPTI CRITICAL CARE ANALYZERK974784AVL OPTI CRITICAL CARE ANALYZER

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Related Devices (Code: GLY)

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.

K050014HEMONIR TMNir Diagnostics, Inc.K993104STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORNova Biomedical Corp.K955013NOVA CO-OXIMETER ANALYZERNova Biomedical Corp.K952725MULTICHECKRadiometer America, 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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