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FDA 510(k)

MODEL 3000 OPTICATH COMPUTER

K-Number: K853018 · 1986-01-13

ApplicantOximetrix, Inc.
Decision Date1986-01-13
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 3000 OPTICATH COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K853018. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3000 OPTICATH COMPUTER?

MODEL 3000 OPTICATH COMPUTER is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Oximetrix, Inc.. The 510(k) number is K853018.

When did MODEL 3000 OPTICATH COMPUTER receive FDA 510(k) clearance?

MODEL 3000 OPTICATH COMPUTER received FDA 510(k) clearance on 1986-01-13, under 510(k) number K853018.

Who is the listed applicant for MODEL 3000 OPTICATH COMPUTER?

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

What is the FDA product code for MODEL 3000 OPTICATH COMPUTER?

The FDA product code for MODEL 3000 OPTICATH COMPUTER is DXG.

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Other records listing Oximetrix, 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.

K842622HEMO STATIC/ESU SCALPEL SYSTEMK833966PUMP INFUSION WEARABLE INFUSION PUMPK823007OPTICATH HEPARIN COATED, FLOW-DIRECTK821056FLOW DIRECTED THERMAL-DILUTION CATHETERK821057FLOW DIRECTED THERMAL-DILUTION INFUSIONK820674OPTICATH

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Related Devices (Code: DXG)

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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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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