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FDA 510(k)

AVL OPTI 1 PH/BLOOD GAS ANALYZER

K-Number: K961161 · 1996-04-26

ApplicantAvl Scientific Corp.
Decision Date1996-04-26
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AVL OPTI 1 PH/BLOOD GAS ANALYZER 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 1996-04-26 under 510(k) number K961161. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVL OPTI 1 PH/BLOOD GAS ANALYZER?

AVL OPTI 1 PH/BLOOD GAS ANALYZER is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is Avl Scientific Corp.. The 510(k) number is K961161.

When did AVL OPTI 1 PH/BLOOD GAS ANALYZER receive FDA 510(k) clearance?

AVL OPTI 1 PH/BLOOD GAS ANALYZER received FDA 510(k) clearance on 1996-04-26, under 510(k) number K961161.

Who is the listed applicant for AVL OPTI 1 PH/BLOOD GAS ANALYZER?

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 OPTI 1 PH/BLOOD GAS ANALYZER?

The FDA product code for AVL OPTI 1 PH/BLOOD GAS ANALYZER is CHL.

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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: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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