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FDA 510(k)

EUROTROL GAS - ISE CONTROL

K-Number: K955340 · 1995-12-26

ApplicantDirect Solutions
Decision Date1995-12-26
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EUROTROL GAS - ISE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Direct Solutions. It received FDA 510(k) clearance on 1995-12-26 under 510(k) number K955340. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROTROL GAS - ISE CONTROL?

EUROTROL GAS - ISE CONTROL is a medical device that received FDA 510(k) clearance on 1995-12-26. The listed applicant is Direct Solutions. The 510(k) number is K955340.

When did EUROTROL GAS - ISE CONTROL receive FDA 510(k) clearance?

EUROTROL GAS - ISE CONTROL received FDA 510(k) clearance on 1995-12-26, under 510(k) number K955340.

Who is the listed applicant for EUROTROL GAS - ISE CONTROL?

The FDA 510(k) record lists Direct Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROTROL GAS - ISE CONTROL?

The FDA product code for EUROTROL GAS - ISE CONTROL is JJS.

Related Clinical Trials

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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Other records listing Direct Solutions 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.

K963909HEMOCUE GLUCOLINK964052HEMOCUE HEMOTROLK964053HEMOCUE GLUCOTROLK963908HEMOCUE HEMOLIN

Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

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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