The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Monitoring Station, Connex(r) Central Station (cs).
| Device ID | K132807 |
| 510k Number | K132807 |
| Device Name: | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Kevin Crossen |
| Correspondent | Kevin Crossen WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094195439 | K132807 | 000 |
| 00732094327113 | K132807 | 000 |
| 00732094294699 | K132807 | 000 |
| 00732094294682 | K132807 | 000 |
| 00732094294675 | K132807 | 000 |
| 00732094294668 | K132807 | 000 |
| 00732094250886 | K132807 | 000 |
| 00732094250879 | K132807 | 000 |
| 00732094244298 | K132807 | 000 |
| 00732094327120 | K132807 | 000 |
| 00732094327137 | K132807 | 000 |
| 00732094327144 | K132807 | 000 |
| 00732094195408 | K132807 | 000 |
| 00732094253207 | K132807 | 000 |
| 00732094253191 | K132807 | 000 |
| 00732094253184 | K132807 | 000 |
| 00732094320169 | K132807 | 000 |
| 00732094320152 | K132807 | 000 |
| 00732094320145 | K132807 | 000 |
| 00732094320138 | K132807 | 000 |
| 00732094345704 | K132807 | 000 |