The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Vital Signs Monitor-vsm 6000 Series.
| Device ID | K101445 |
| 510k Number | K101445 |
| Device Name: | VITAL SIGNS MONITOR-VSM 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 | Hy Doan |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-24 |
| Decision Date | 2010-06-08 |
| Summary: | summary |