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FDA 510(k)

OXYGENATOR, COBE CATALOG #42-220

K-Number: K790356 · 1979-03-09

ApplicantCobe Laboratories, Inc.
Decision Date1979-03-09
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYGENATOR, COBE CATALOG #42-220 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1979-03-09 under 510(k) number K790356. 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, COBE CATALOG #42-220?

OXYGENATOR, COBE CATALOG #42-220 is a medical device that received FDA 510(k) clearance on 1979-03-09. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K790356.

When did OXYGENATOR, COBE CATALOG #42-220 receive FDA 510(k) clearance?

OXYGENATOR, COBE CATALOG #42-220 received FDA 510(k) clearance on 1979-03-09, under 510(k) number K790356.

Who is the listed applicant for OXYGENATOR, COBE CATALOG #42-220?

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

What is the FDA product code for OXYGENATOR, COBE CATALOG #42-220?

The FDA product code for OXYGENATOR, COBE CATALOG #42-220 is DTZ.

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Other records listing Cobe Laboratories, Inc. as applicant

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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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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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