Submission Details
| 510(k) Number | K011328 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 2001 |
| Decision Date | November 21, 2001 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
Nov 2001
Decision
204d
Days
—
Risk
About This 510(k) Submission
K011328 is an FDA 510(k) clearance for the CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH, submitted by Bionet Company, Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 21, 2001, 204 days after receiving the submission on May 1, 2001. This device falls under the Cardiovascular review panel.
Device Classification
| Product Code | LOS |
| Device Class | — |
Manufacturer
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