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FDA 510(k)

BIOCOR 200 HIGH PERFORMANCEOXYGENATOR

K-Number: K964967 · 1997-03-06

ApplicantMinntech Corp.
Decision Date1997-03-06
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCOR 200 HIGH PERFORMANCEOXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1997-03-06 under 510(k) number K964967. 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 BIOCOR 200 HIGH PERFORMANCEOXYGENATOR?

BIOCOR 200 HIGH PERFORMANCEOXYGENATOR is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Minntech Corp.. The 510(k) number is K964967.

When did BIOCOR 200 HIGH PERFORMANCEOXYGENATOR receive FDA 510(k) clearance?

BIOCOR 200 HIGH PERFORMANCEOXYGENATOR received FDA 510(k) clearance on 1997-03-06, under 510(k) number K964967.

Who is the listed applicant for BIOCOR 200 HIGH PERFORMANCEOXYGENATOR?

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

What is the FDA product code for BIOCOR 200 HIGH PERFORMANCEOXYGENATOR?

The FDA product code for BIOCOR 200 HIGH PERFORMANCEOXYGENATOR is DTZ.

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Other records listing Minntech Corp. as applicant

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K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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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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