FDA 510(k)

HDM97

K-Number: K020908 · 2002-05-22

Decision Date2002-05-22

Product CodeFIZ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HDM97 is the device name listed in this FDA 510(k) record. The listed applicant is Ibp Instruments GmbH. It received FDA 510(k) clearance on 2002-05-22 under 510(k) number K020908. The device is classified under product code FIZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDM97?

HDM97 is a medical device that received FDA 510(k) clearance on 2002-05-22. The listed applicant is Ibp Instruments GmbH. The 510(k) number is K020908.

When did HDM97 receive FDA 510(k) clearance?

HDM97 received FDA 510(k) clearance on 2002-05-22, under 510(k) number K020908.

Who is the listed applicant for HDM97?

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

What is the FDA product code for HDM97?

The FDA product code for HDM97 is FIZ.

Other records listing Ibp Instruments GmbH 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.

K032075CONDUCTIVITY STANDARD SOLUTION-METERCARE K020909HDM99

Related Devices (Code: FIZ)

K201765SmartHDM-510 SystemMesa Laboratories, Inc.K05081290XL INSTRUMENTATION SYSTEMMesa Laboratories, Inc.K020909HDM99Ibp Instruments GmbH K992431NEO-2 METERAutomata Instrumentation, Inc.K981294ODYSSEY INSTRUMENTATION SYSTEMAutomata Instrumentation, Inc.K955298PHOENIX DIALYSATE METERAutomata Medical Instrumentation, Inc.

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.