The following data is part of a premarket notification filed by Extension , Inc with the FDA for Clinical Alert Notification.
| Device ID | K130339 |
| 510k Number | K130339 |
| Device Name: | CLINICAL ALERT NOTIFICATION |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | EXTENSION , INC 7250 SW 154TH TERRACE Beaverton, OR 97007 |
| Contact | Tim Gee |
| Correspondent | Tim Gee EXTENSION , INC 7250 SW 154TH TERRACE Beaverton, OR 97007 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002177779 | K130339 | 000 |
| 00860002177786 | K130339 | 000 |
| 00860002177762 | K130339 | 000 |
| 00860002177755 | K130339 | 000 |
| 00860002177748 | K130339 | 000 |
| 00860002177731 | K130339 | 000 |
| 00860002177724 | K130339 | 000 |
| 00860002177717 | K130339 | 000 |
| 00860002177700 | K130339 | 000 |