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FDA 510(k)

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S

K-Number: K802719 · 1980-12-16

ApplicantBentley Laboratories, Inc.
Decision Date1980-12-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S 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 1980-12-16 under 510(k) number K802719. 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 SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S?

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K802719.

When did SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S receive FDA 510(k) clearance?

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802719.

Who is the listed applicant for SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S?

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 SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S?

The FDA product code for SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S 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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