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)

ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.

K-Number: K894991 · 1989-10-26

ApplicantLabeltape Meditect, Inc.
Decision Date1989-10-26
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1989-10-26 under 510(k) number K894991. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.?

ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. is a medical device that received FDA 510(k) clearance on 1989-10-26. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K894991.

When did ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. receive FDA 510(k) clearance?

ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. received FDA 510(k) clearance on 1989-10-26, under 510(k) number K894991.

Who is the listed applicant for ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.?

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

What is the FDA product code for ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.?

The FDA product code for ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. is DRX.

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 Labeltape Meditect, 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.

K951328LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORDK915333ELECTRODE USING PROMEON RG-60 SERIES GELK914871TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GELK912979HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATIONK902738ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTHK902719SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT

View all 26 devices →

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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.

↑