The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Connex Vital Signs Monitor 6000 Series.
| Device ID | K121013 |
| 510k Number | K121013 |
| Device Name: | CONNEX VITAL SIGNS MONITOR 6000 SERIES |
| 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 | 2012-04-03 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094221763 | K121013 | 000 |
| 00732094300123 | K121013 | 000 |
| 00732094300093 | K121013 | 000 |
| 00732094300086 | K121013 | 000 |
| 00732094300079 | K121013 | 000 |
| 00732094300055 | K121013 | 000 |
| 00732094300024 | K121013 | 000 |
| 00732094300017 | K121013 | 000 |
| 00732094300000 | K121013 | 000 |