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FDA 510(k)

OXYGENATOR MODEL NO. BENTLEY 5 PLUS

K-Number: K872133 · 1987-08-24

ApplicantAmerican Bentley
Decision Date1987-08-24
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYGENATOR MODEL NO. BENTLEY 5 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1987-08-24 under 510(k) number K872133. 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 OXYGENATOR MODEL NO. BENTLEY 5 PLUS?

OXYGENATOR MODEL NO. BENTLEY 5 PLUS is a medical device that received FDA 510(k) clearance on 1987-08-24. The listed applicant is American Bentley. The 510(k) number is K872133.

When did OXYGENATOR MODEL NO. BENTLEY 5 PLUS receive FDA 510(k) clearance?

OXYGENATOR MODEL NO. BENTLEY 5 PLUS received FDA 510(k) clearance on 1987-08-24, under 510(k) number K872133.

Who is the listed applicant for OXYGENATOR MODEL NO. BENTLEY 5 PLUS?

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 OXYGENATOR MODEL NO. BENTLEY 5 PLUS?

The FDA product code for OXYGENATOR MODEL NO. BENTLEY 5 PLUS 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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