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FDA 510(k)

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

K-Number: K032608 · 2003-10-21

ApplicantGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
Decision Date2003-10-21
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K032608. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER?

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB. The 510(k) number is K032608.

When did GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER receive FDA 510(k) clearance?

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER received FDA 510(k) clearance on 2003-10-21, under 510(k) number K032608.

Who is the listed applicant for GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER?

The FDA 510(k) record lists Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER?

The FDA product code for GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER is JIS.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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