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FDA 510(k)

IRMA BLOOD ANALYSIS SYSTEM

K-Number: K981270 · 1998-05-01

ApplicantDiametrics Medical, Inc.
Decision Date1998-05-01
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA BLOOD ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diametrics Medical, Inc.. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K981270. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA BLOOD ANALYSIS SYSTEM?

IRMA BLOOD ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Diametrics Medical, Inc.. The 510(k) number is K981270.

When did IRMA BLOOD ANALYSIS SYSTEM receive FDA 510(k) clearance?

IRMA BLOOD ANALYSIS SYSTEM received FDA 510(k) clearance on 1998-05-01, under 510(k) number K981270.

Who is the listed applicant for IRMA BLOOD ANALYSIS SYSTEM?

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

What is the FDA product code for IRMA BLOOD ANALYSIS SYSTEM?

The FDA product code for IRMA BLOOD ANALYSIS SYSTEM is CGZ.

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Other records listing Diametrics Medical, Inc. as applicant

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K030035IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGEK013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEK980523IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGEK974396IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULEK945240IRMA BLOOD ANALYSIS SYSTEM

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Related Devices (Code: CGZ)

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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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