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)

DISPOSABLE ELECTRODE, #1610

K-Number: K812276 · 1981-09-25

ApplicantAndover Medical, Inc.
Decision Date1981-09-25
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ELECTRODE, #1610 is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1981-09-25 under 510(k) number K812276. 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 DISPOSABLE ELECTRODE, #1610?

DISPOSABLE ELECTRODE, #1610 is a medical device that received FDA 510(k) clearance on 1981-09-25. The listed applicant is Andover Medical, Inc.. The 510(k) number is K812276.

When did DISPOSABLE ELECTRODE, #1610 receive FDA 510(k) clearance?

DISPOSABLE ELECTRODE, #1610 received FDA 510(k) clearance on 1981-09-25, under 510(k) number K812276.

Who is the listed applicant for DISPOSABLE ELECTRODE, #1610?

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

What is the FDA product code for DISPOSABLE ELECTRODE, #1610?

The FDA product code for DISPOSABLE ELECTRODE, #1610 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 Andover Medical, 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.

K905729CANMED 451K903427NORTECH MODEL 86901000 ELECTRODEK885171MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLEK860636FASTRACE III, ECG ELECTRODEK854433ECG MONITORING/DEFIBRILLATION ELECTRODEK860535UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)

View all 21 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.

↑