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)

ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.

K-Number: K911990 · 1991-06-21

ApplicantSomnitec, Inc.
Decision Date1991-06-21
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. is the device name listed in this FDA 510(k) record. The listed applicant is Somnitec, Inc.. It received FDA 510(k) clearance on 1991-06-21 under 510(k) number K911990. 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 ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.?

ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. is a medical device that received FDA 510(k) clearance on 1991-06-21. The listed applicant is Somnitec, Inc.. The 510(k) number is K911990.

When did ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. receive FDA 510(k) clearance?

ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. received FDA 510(k) clearance on 1991-06-21, under 510(k) number K911990.

Who is the listed applicant for ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.?

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

What is the FDA product code for ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.?

The FDA product code for ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. 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 Somnitec, 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.

K911989GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.K912817SOMNIMIC (R)K912234SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION

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.

↑