The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Vsm Vital Signs Monitor, Model 53000 (vsm 300).
| Device ID | K053027 |
| 510k Number | K053027 |
| Device Name: | VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WELCH ALLYN, INC. 4341 SOUTH STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John E Sawyer |
| Correspondent | John E Sawyer WELCH ALLYN, INC. 4341 SOUTH 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 | 2005-10-27 |
| Decision Date | 2005-11-22 |
| Summary: | summary |