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FDA 510(k)

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE

K-Number: K980523 · 1998-03-19

ApplicantDiametrics Medical, Inc.
Decision Date1998-03-19
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE 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 1998-03-19 under 510(k) number K980523. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE?

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE is a medical device that received FDA 510(k) clearance on 1998-03-19. The listed applicant is Diametrics Medical, Inc.. The 510(k) number is K980523.

When did IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE receive FDA 510(k) clearance?

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE received FDA 510(k) clearance on 1998-03-19, under 510(k) number K980523.

Who is the listed applicant for IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE?

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 WITH OPTIONAL MULTI-USE CARTRIDGE?

The FDA product code for IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE is CHL.

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Other records listing Diametrics Medical, 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.

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Related Devices (Code: CHL)

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.

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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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