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FDA 510(k)

IONOMETER EH-HK AND ACCESSORIES

K-Number: K901041 · 1990-06-18

ApplicantFresenius USA, Inc.
Decision Date1990-06-18
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IONOMETER EH-HK AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1990-06-18 under 510(k) number K901041. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONOMETER EH-HK AND ACCESSORIES?

IONOMETER EH-HK AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K901041.

When did IONOMETER EH-HK AND ACCESSORIES receive FDA 510(k) clearance?

IONOMETER EH-HK AND ACCESSORIES received FDA 510(k) clearance on 1990-06-18, under 510(k) number K901041.

Who is the listed applicant for IONOMETER EH-HK AND ACCESSORIES?

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

What is the FDA product code for IONOMETER EH-HK AND ACCESSORIES?

The FDA product code for IONOMETER EH-HK AND ACCESSORIES is CEM.

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Related Devices (Code: CEM)

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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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