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FDA 510(k)

AMERICAN BENTLEY OXYGENATOR MAX-2

K-Number: K851035 · 1985-05-16

ApplicantAmerican Bentley
Decision Date1985-05-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMERICAN BENTLEY OXYGENATOR MAX-2 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1985-05-16 under 510(k) number K851035. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN BENTLEY OXYGENATOR MAX-2?

AMERICAN BENTLEY OXYGENATOR MAX-2 is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is American Bentley. The 510(k) number is K851035.

When did AMERICAN BENTLEY OXYGENATOR MAX-2 receive FDA 510(k) clearance?

AMERICAN BENTLEY OXYGENATOR MAX-2 received FDA 510(k) clearance on 1985-05-16, under 510(k) number K851035.

Who is the listed applicant for AMERICAN BENTLEY OXYGENATOR MAX-2?

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

What is the FDA product code for AMERICAN BENTLEY OXYGENATOR MAX-2?

The FDA product code for AMERICAN BENTLEY OXYGENATOR MAX-2 is DTZ.

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Related Devices (Code: DTZ)

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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