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 |