Bunny Electrode/Stealth Electrode Pre Wired EEG

Q: What is the product code of K911529?

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

FDA 510(k) K911529 · Lead-Lok, Inc.

Substantially Equivalent

510(k) numberK911529

Submission

Device name: Bunny Electrode/Stealth Electrode Pre Wired EEG
Applicant: Lead-Lok, Inc.
Sandpoint, ID, US
Received: April 4, 1991
Decision date: November 9, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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

Other 510(k)s with product code DRX

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K100315	12 Lead GloveDRX · Special	I Needmd, Inc.	04/23/2010SE
K092744	Neonatal ECG Electrode, M203KENDRX · Traditional	R & D Medical Products, Inc.	12/10/2009SE
K092389	Disposal ECG Electrodes, Model EasyrodeDRX · Traditional	Suzuken Co., Ltd.	10/13/2009SE

More from Suzuken Co., Ltd.

510(k)	Device	Decision
K010431	Lead-Lok Reusable Tens/ Nmes ElectrodesGXY · Traditional	09/06/2001SE
K911518	Bunny Electrode/Stealth Solid Gel-Snap on FoamDRX · Traditional	11/09/1992SE
K903729	Gold GatorsDRY · Traditional	09/14/1990SE
K895100	Echo Gel (Rainforest)ITX · Traditional	11/03/1989SE

Questions and answers

When was Bunny Electrode/Stealth Electrode Pre Wired EEG cleared by the FDA?

Bunny Electrode/Stealth Electrode Pre Wired EEG (K911529) received a 510(k) decision of Substantially Equivalent on November 9, 1992, 585 days after the submission was received.

What is the product code of K911529?

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