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FDA 510(k)

IONOMETER EF-HK AND ACCESSORIES

K-Number: K901042 · 1990-07-31

ApplicantFresenius USA, Inc.
Decision Date1990-07-31
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IONOMETER EF-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 1990-07-31 under 510(k) number K901042. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONOMETER EF-HK AND ACCESSORIES?

IONOMETER EF-HK AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K901042.

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

IONOMETER EF-HK AND ACCESSORIES received FDA 510(k) clearance on 1990-07-31, under 510(k) number K901042.

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

The FDA product code for IONOMETER EF-HK AND ACCESSORIES is JGS.

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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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