Modification of Cardiointegram/Cardiointegraph

FDA 510(k) K863153 · Ocg Technology, Inc.

Substantially Equivalent

510(k) numberK863153

Submission

Device name
Modification of Cardiointegram/Cardiointegraph
Applicant
Ocg Technology, Inc.
Farmingdale, NY, US
Received
August 15, 1986
Decision date
January 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1435
Specialty
Cardiovascular

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More from Lidco, Ltd.

510(k)DeviceDecision
K862947The Expert Models RTS 2000 and RTS 2000HDSI · Traditional 11/04/1987SE
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Questions and answers

When was Modification of Cardiointegram/Cardiointegraph cleared by the FDA?

Modification of Cardiointegram/Cardiointegraph (K863153) received a 510(k) decision of Substantially Equivalent on January 6, 1987, 144 days after the submission was received.

What is the product code of K863153?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.