Modification to Sphygmocor Cardiovascular Management System

FDA 510(k) K080670 · Atcor Medical

Substantially Equivalent

510(k) numberK080670

Submission

Device name
Modification to Sphygmocor Cardiovascular Management System
Applicant
Atcor Medical
West Ryde Nsw, AU
Received
March 10, 2008
Decision date
April 23, 2008
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSK – Computer, Blood-Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1110
Specialty
Cardiovascular

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K012487Sphygmocor PX Model Scor-PxDXN · Traditional 02/21/2002SE

Questions and answers

When was Modification to Sphygmocor Cardiovascular Management System cleared by the FDA?

Modification to Sphygmocor Cardiovascular Management System (K080670) received a 510(k) decision of Substantially Equivalent on April 23, 2008, 44 days after the submission was received.

What is the product code of K080670?

The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.