Cardio Care EKG-2000 12-CHANNEL Electrocardiograph
FDA 510(k) K011328 · Bionet Company, Ltd.
510(k) numberK011328
Submission
- Device name
- Cardio Care EKG-2000 12-CHANNEL Electrocardiograph
- Applicant
- Bionet Company, Ltd.
Seoul, KR - Received
- May 1, 2001
- Decision date
- November 21, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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Questions and answers
When was Cardio Care EKG-2000 12-CHANNEL Electrocardiograph cleared by the FDA?
Cardio Care EKG-2000 12-CHANNEL Electrocardiograph (K011328) received a 510(k) decision of Substantially Equivalent on November 21, 2001, 204 days after the submission was received.