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FDA 510(k)

OXYGENATOR, BLOOD BOS-10

K-Number: K781842 · 1978-11-08

ApplicantBentley Laboratories, Inc.
Decision Date1978-11-08
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYGENATOR, BLOOD BOS-10 is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781842. 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, BLOOD BOS-10?

OXYGENATOR, BLOOD BOS-10 is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K781842.

When did OXYGENATOR, BLOOD BOS-10 receive FDA 510(k) clearance?

OXYGENATOR, BLOOD BOS-10 received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781842.

Who is the listed applicant for OXYGENATOR, BLOOD BOS-10?

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

What is the FDA product code for OXYGENATOR, BLOOD BOS-10?

The FDA product code for OXYGENATOR, BLOOD BOS-10 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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