EHC400 Desktop Patient Station; EHC600 Care Provider Station

FDA 510(k) K002984 · Cybercare Technologies, Inc.

Substantially Equivalent

510(k) numberK002984

Submission

Device name
EHC400 Desktop Patient Station; EHC600 Care Provider Station
Applicant
Cybercare Technologies, Inc.
Atlanta, GA, US
Received
September 25, 2000
Decision date
December 18, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQD – Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

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More from Sparrow Acoustics, Inc.

510(k)DeviceDecision
K003485Care Provider Station Addition of Weight ScaleDQD · Traditional 01/11/2001SE
K003257EHC400 Desktop Patient Station; ECH600 Care Provider StationCGA · Traditional 12/22/2000SE

Questions and answers

When was EHC400 Desktop Patient Station; EHC600 Care Provider Station cleared by the FDA?

EHC400 Desktop Patient Station; EHC600 Care Provider Station (K002984) received a 510(k) decision of Substantially Equivalent on December 18, 2000, 84 days after the submission was received.

What is the product code of K002984?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.