The following data is part of a premarket notification filed by Schiller Ag with the FDA for Welch Allyn 1500 Patient Monitor.
| Device ID | K101619 |
| 510k Number | K101619 |
| Device Name: | WELCH ALLYN 1500 PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SCHILLER AG ALTGASSE 68 Baar, Zg, CH 6341 |
| Contact | Serkan Sezer |
| Correspondent | Serkan Sezer SCHILLER AG ALTGASSE 68 Baar, Zg, CH 6341 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2010-11-12 |
| Summary: | summary |