ECG Female-To-Pin Snap Electrode W/Leads and Ext.

FDA 510(k) K911990 · Somnitec, Inc.

Substantially Equivalent

510(k) numberK911990

Submission

Device name
ECG Female-To-Pin Snap Electrode W/Leads and Ext.
Applicant
Somnitec, Inc.
Van Nuys, CA, US
Received
May 6, 1991
Decision date
June 21, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DRX – Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Specialty
Cardiovascular

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More from Suzuken Co., Ltd.

510(k)DeviceDecision
K911989Gold Cup EEG Cutaneous Electrode W/Lead and Ext.GXY · Traditional 07/30/1991SE
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Questions and answers

When was ECG Female-To-Pin Snap Electrode W/Leads and Ext. cleared by the FDA?

ECG Female-To-Pin Snap Electrode W/Leads and Ext. (K911990) received a 510(k) decision of Substantially Equivalent on June 21, 1991, 46 days after the submission was received.

What is the product code of K911990?

The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.