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FDA 510(k)

ZAK-2000

K-Number: K972022 · 1998-01-22

ApplicantCardio Systems, Inc.
Decision Date1998-01-22
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZAK-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Systems, Inc.. It received FDA 510(k) clearance on 1998-01-22 under 510(k) number K972022. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAK-2000?

ZAK-2000 is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Cardio Systems, Inc.. The 510(k) number is K972022.

When did ZAK-2000 receive FDA 510(k) clearance?

ZAK-2000 received FDA 510(k) clearance on 1998-01-22, under 510(k) number K972022.

Who is the listed applicant for ZAK-2000?

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

What is the FDA product code for ZAK-2000?

The FDA product code for ZAK-2000 is FNM.

Other records listing Cardio Systems, Inc. as applicant

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Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.K955243BARIAIRKinetic Concepts, Inc.

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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