K-Klip

FDA 510(k) K940801 · Katecho, Inc.

Substantially Equivalent

510(k) numberK940801

Submission

Device name
K-Klip
Applicant
Katecho, Inc.
Des Moines, IA, US
Received
February 22, 1994
Decision date
August 3, 1994
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.

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K981737K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional 12/09/1998SE
K954504K-Defib/Pace Pediatric ElectrodeMKJ · Traditional 11/17/1995SE
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Questions and answers

When was K-Klip cleared by the FDA?

K-Klip (K940801) received a 510(k) decision of Substantially Equivalent on August 3, 1994, 162 days after the submission was received.

What is the product code of K940801?

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