The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Vsm - Vital Signs Monitor, Model 53000 Series.
| Device ID | K031740 |
| 510k Number | K031740 |
| Device Name: | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES |
| Classification | Oximeter |
| Applicant | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Contact | James W Sandberg |
| Correspondent | James W Sandberg WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2003-08-26 |
| Summary: | summary |