The following data is part of a premarket notification filed by Viasys Medsystems with the FDA for Pulmanex Disposable Pressure Manometer, Model 50-5000.
| Device ID | K050309 |
| 510k Number | K050309 |
| Device Name: | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-08 |
| Decision Date | 2005-03-25 |