Cardio Perfect, Cardio Perfect MD

FDA 510(k) K922898 · Cardio Control BV

Substantially Equivalent

510(k) numberK922898

Submission

Device name
Cardio Perfect, Cardio Perfect MD
Applicant
Cardio Control BV
The Netherlands, NL
Received
June 16, 1992
Decision date
November 1, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

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K991735Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac Vu, Mac 8…LOS · Traditional General Electric Medical Systems Information Techn08/19/1999SE
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More from Nihon Kohden America, Inc.

510(k)DeviceDecision
K962854Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0…LOS · Traditional 01/27/1997SE
K935732Cardio Perfect ST 2001DSI · Traditional 04/04/1996SE
K913374Cardio Perfect, Cardio Perfect MDDPS · Traditional 01/23/1992SE

Questions and answers

When was Cardio Perfect, Cardio Perfect MD cleared by the FDA?

Cardio Perfect, Cardio Perfect MD (K922898) received a 510(k) decision of Substantially Equivalent on November 1, 1993, 503 days after the submission was received.