Submission Details
| 510(k) Number | K023034 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2002 |
| Decision Date | November 14, 2002 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CARDIOTOUCH-3000
Nov 2002
Decision
63d
Days
—
Risk
About This 510(k) Submission
K023034 is an FDA 510(k) clearance for the CARDIOTOUCH-3000, submitted by Bionet Company, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on November 14, 2002, 63 days after receiving the submission on September 12, 2002. This device falls under the Cardiovascular review panel.
Device Classification
| Product Code | LOS |
| Device Class | — |
Manufacturer
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