Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFIED SODIUM ELECTRODE

K-Number: K863907 · 1986-12-10

ApplicantIonetics, Inc.
Decision Date1986-12-10
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED SODIUM ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ionetics, Inc.. It received FDA 510(k) clearance on 1986-12-10 under 510(k) number K863907. 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 MODIFIED SODIUM ELECTRODE?

MODIFIED SODIUM ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-12-10. The listed applicant is Ionetics, Inc.. The 510(k) number is K863907.

When did MODIFIED SODIUM ELECTRODE receive FDA 510(k) clearance?

MODIFIED SODIUM ELECTRODE received FDA 510(k) clearance on 1986-12-10, under 510(k) number K863907.

Who is the listed applicant for MODIFIED SODIUM ELECTRODE?

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

What is the FDA product code for MODIFIED SODIUM ELECTRODE?

The FDA product code for MODIFIED SODIUM ELECTRODE is JGS.

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 Ionetics, Inc. 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.

K932179MODEL 400/450 ELECTROLYTE ANALYZERK895397CALCIUM AND PH ELECTROLYTE ANALYZERK890792POTASSIUM AND SODIUM ELECTROLYTE ANALYZERK851808ELECTROLYTE ANALYZERK830130MINIATURE ION SELECTIVE ELECTRODESK802856MINIATURE ION SELECTIVE ELECTRODES

View all 7 devices →

Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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.

↑