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FDA 510(k)

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010

K-Number: K992559 · 1999-09-20

ApplicantJostra Bentley
Decision Date1999-09-20
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 is the device name listed in this FDA 510(k) record. The listed applicant is Jostra Bentley. It received FDA 510(k) clearance on 1999-09-20 under 510(k) number K992559. 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 HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010?

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 is a medical device that received FDA 510(k) clearance on 1999-09-20. The listed applicant is Jostra Bentley. The 510(k) number is K992559.

When did HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 receive FDA 510(k) clearance?

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 received FDA 510(k) clearance on 1999-09-20, under 510(k) number K992559.

Who is the listed applicant for HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010?

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

What is the FDA product code for HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010?

The FDA product code for HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 is DTZ.

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Other records listing Jostra Bentley as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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