The following data is part of a premarket notification filed by Capsule Technologie Sas with the FDA for Smartlinx Vitals Plus Patient Monitoring System.
| Device ID | K151071 |
| 510k Number | K151071 |
| Device Name: | SmartLinx Vitals Plus Patient Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | CAPSULE TECHNOLOGIE SAS 300 BRICKSTONE SQURE, SUITE 203 Andover, MA 01810 |
| Contact | Peter Kelley |
| Correspondent | Peter Kelley CAPSULE TECHNOLOGIE SAS 300 BRICKSTONE SQURE, SUITE 203 Andover, MA 01810 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-21 |
| Decision Date | 2015-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03615040000438 | K151071 | 000 |
| 03615040000230 | K151071 | 000 |
| 03615040000223 | K151071 | 000 |
| 03615040000032 | K151071 | 000 |
| 03615040000018 | K151071 | 000 |
| 03615040000025 | K151071 | 000 |
| 03615040000001 | K151071 | 000 |
| 03615040000155 | K151071 | 000 |
| 03615040000148 | K151071 | 000 |
| 03615040000131 | K151071 | 000 |
| 03615040000124 | K151071 | 000 |
| 03615040000070 | K151071 | 000 |
| 03615040000063 | K151071 | 000 |
| 03615040000056 | K151071 | 000 |
| 03615040000247 | K151071 | 000 |
| 03615040000308 | K151071 | 000 |
| 03615040000315 | K151071 | 000 |
| 03615040000421 | K151071 | 000 |
| 03615040000414 | K151071 | 000 |
| 03615040000407 | K151071 | 000 |
| 03615040000292 | K151071 | 000 |
| 03615040000278 | K151071 | 000 |
| 03615040000117 | K151071 | 000 |
| 03615040000100 | K151071 | 000 |
| 03615040000285 | K151071 | 000 |
| 03615040000261 | K151071 | 000 |
| 03615040000094 | K151071 | 000 |
| 03615040000087 | K151071 | 000 |
| 03615040000254 | K151071 | 000 |
| 03615040000322 | K151071 | 000 |
| 03615040000049 | K151071 | 000 |