The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Connex Vital Solutions Software.
| Device ID | K053381 |
| 510k Number | K053381 |
| Device Name: | WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE |
| Classification | Oximeter |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Chris Klaczyk |
| Correspondent | Chris Klaczyk WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-06-15 |
| Summary: | summary |