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FDA 510(k)

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B

K-Number: K860673 · 1986-06-26

ApplicantAmerican Bentley
Decision Date1986-06-26
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1986-06-26 under 510(k) number K860673. 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 NOS. BENTLEY-10A & BENTLEY-10B?

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B is a medical device that received FDA 510(k) clearance on 1986-06-26. The listed applicant is American Bentley. The 510(k) number is K860673.

When did OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B receive FDA 510(k) clearance?

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B received FDA 510(k) clearance on 1986-06-26, under 510(k) number K860673.

Who is the listed applicant for OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B?

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 NOS. BENTLEY-10A & BENTLEY-10B?

The FDA product code for OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B is DTZ.

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Related Devices (Code: DTZ)

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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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