The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Connex(r) Vital Signs Monitor 6000 Series.
| Device ID | K112687 |
| 510k Number | K112687 |
| Device Name: | CONNEX(R) 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 | 2011-09-15 |
| Decision Date | 2011-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094150179 | K112687 | 000 |
| 00732094056112 | K112687 | 000 |
| 00732094056075 | K112687 | 000 |
| 00732094056020 | K112687 | 000 |
| 00732094056006 | K112687 | 000 |
| 00732094055849 | K112687 | 000 |
| 00732094055740 | K112687 | 000 |
| 00732094055597 | K112687 | 000 |
| 00732094055535 | K112687 | 000 |
| 00732094055467 | K112687 | 000 |
| 00732094055412 | K112687 | 000 |
| 00732094055207 | K112687 | 000 |
| 00732094055054 | K112687 | 000 |
| 00732094300116 | K112687 | 000 |
| 00732094300109 | K112687 | 000 |
| 00732094300062 | K112687 | 000 |
| 00732094300048 | K112687 | 000 |
| 00732094056174 | K112687 | 000 |
| 00732094057027 | K112687 | 000 |
| 00732094057676 | K112687 | 000 |
| 00732094119336 | K112687 | 000 |
| 00732094118964 | K112687 | 000 |
| 00732094118940 | K112687 | 000 |
| 00732094118926 | K112687 | 000 |
| 00732094118902 | K112687 | 000 |
| 00732094118889 | K112687 | 000 |
| 00732094118865 | K112687 | 000 |
| 00732094118841 | K112687 | 000 |
| 00732094118827 | K112687 | 000 |
| 00732094118803 | K112687 | 000 |
| 00732094118780 | K112687 | 000 |
| 00732094118773 | K112687 | 000 |
| 00732094062540 | K112687 | 000 |
| 00732094058352 | K112687 | 000 |
| 00732094057775 | K112687 | 000 |
| 00732094057713 | K112687 | 000 |
| 00732094300031 | K112687 | 000 |