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FDA 510(k)

BLOOD OXYGENATOR MODEL NO. MAX-5

K-Number: K850630 · 1985-03-27

ApplicantAmerican Bentley
Decision Date1985-03-27
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD OXYGENATOR MODEL NO. MAX-5 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1985-03-27 under 510(k) number K850630. 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 BLOOD OXYGENATOR MODEL NO. MAX-5?

BLOOD OXYGENATOR MODEL NO. MAX-5 is a medical device that received FDA 510(k) clearance on 1985-03-27. The listed applicant is American Bentley. The 510(k) number is K850630.

When did BLOOD OXYGENATOR MODEL NO. MAX-5 receive FDA 510(k) clearance?

BLOOD OXYGENATOR MODEL NO. MAX-5 received FDA 510(k) clearance on 1985-03-27, under 510(k) number K850630.

Who is the listed applicant for BLOOD OXYGENATOR MODEL NO. MAX-5?

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 BLOOD OXYGENATOR MODEL NO. MAX-5?

The FDA product code for BLOOD OXYGENATOR MODEL NO. MAX-5 is DTZ.

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Other records listing American Bentley as applicant

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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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