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FDA 510(k)

G.E.M. WATER SYSTEMS, INTERNATIONAL

K-Number: K970674 · 1997-11-19

ApplicantG.E.M. Water Systems
Decision Date1997-11-19
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

G.E.M. WATER SYSTEMS, INTERNATIONAL is the device name listed in this FDA 510(k) record. The listed applicant is G.E.M. Water Systems. It received FDA 510(k) clearance on 1997-11-19 under 510(k) number K970674. The device is classified under product code FIN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.E.M. WATER SYSTEMS, INTERNATIONAL?

G.E.M. WATER SYSTEMS, INTERNATIONAL is a medical device that received FDA 510(k) clearance on 1997-11-19. The listed applicant is G.E.M. Water Systems. The 510(k) number is K970674.

When did G.E.M. WATER SYSTEMS, INTERNATIONAL receive FDA 510(k) clearance?

G.E.M. WATER SYSTEMS, INTERNATIONAL received FDA 510(k) clearance on 1997-11-19, under 510(k) number K970674.

Who is the listed applicant for G.E.M. WATER SYSTEMS, INTERNATIONAL?

The FDA 510(k) record lists G.E.M. Water Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G.E.M. WATER SYSTEMS, INTERNATIONAL?

The FDA product code for G.E.M. WATER SYSTEMS, INTERNATIONAL is FIN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing G.E.M. Water Systems 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.

K944493REVERSE OSMOSIS SYSTEMK944492DIALYZER REPROCESSING SYSTEM

Related Devices (Code: FIN)

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.

K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.K093641TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLCK060333DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEMDialysis Services, Inc.K051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISAmeriwaterK031502USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMUsfilterK033118BIPRO MODEL SDS-CB200Medical Solutions International

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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