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)

GERARD MEDICAL ELECTRODE TESTER

K-Number: K813358 · 1981-12-29

ApplicantGerard Medical Enterprises, Inc.
Decision Date1981-12-29
Product CodeKRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GERARD MEDICAL ELECTRODE TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Gerard Medical Enterprises, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813358. The device is classified under product code KRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GERARD MEDICAL ELECTRODE TESTER?

GERARD MEDICAL ELECTRODE TESTER is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Gerard Medical Enterprises, Inc.. The 510(k) number is K813358.

When did GERARD MEDICAL ELECTRODE TESTER receive FDA 510(k) clearance?

GERARD MEDICAL ELECTRODE TESTER received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813358.

Who is the listed applicant for GERARD MEDICAL ELECTRODE TESTER?

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

What is the FDA product code for GERARD MEDICAL ELECTRODE TESTER?

The FDA product code for GERARD MEDICAL ELECTRODE TESTER is KRC.

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 Gerard Medical Enterprises, 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.

K954258TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)K945250TRIMPORTK942623TRIMPORTK922147DUAL PLASTIC VASCULAR ACCESS SYSTEMK913114TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORTK912111MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE

View all 8 devices →

Related Devices (Code: KRC)

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.

K023713SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000Sontra Medical, Inc.K872370BIOMA 3500E.B.S., Inc.K874327SKIN PREP ANALYZERMarquette Electronics, Inc.K874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERCircadian, Inc.K840358IMPEDANCE/8200 MONITOR-MODEL 8300Aequitron Medical, Inc.K833619CONDUCTANCE METERCircadian, Inc.

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.

↑