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FDA 510(k)

BLOOD OXYGENATORS #BOS-105S BOS-5S W/

K-Number: K822803 · 1982-11-01

ApplicantBentley Laboratories, Inc.
Decision Date1982-11-01
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD OXYGENATORS #BOS-105S BOS-5S W/ 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 1982-11-01 under 510(k) number K822803. 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 OXYGENATORS #BOS-105S BOS-5S W/?

BLOOD OXYGENATORS #BOS-105S BOS-5S W/ is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K822803.

When did BLOOD OXYGENATORS #BOS-105S BOS-5S W/ receive FDA 510(k) clearance?

BLOOD OXYGENATORS #BOS-105S BOS-5S W/ received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822803.

Who is the listed applicant for BLOOD OXYGENATORS #BOS-105S BOS-5S W/?

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 BLOOD OXYGENATORS #BOS-105S BOS-5S W/?

The FDA product code for BLOOD OXYGENATORS #BOS-105S BOS-5S W/ 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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