K822626 is an FDA 510(k) clearance for the ATC BIOELECTROGRAPHIC MONITOR MODEL I...
Submitted by Advantage Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1982, 13 days after receiving the submission on September 2, 1982.
This device falls under the Obstetrics & Gynecology FDA review panel.
| 510(k) Number | K822626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1982 |
| Decision Date | September 15, 1982 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | - |
| Device Class | - |