The following data is part of a premarket notification filed by Acutronic Medical Systems Ag with the FDA for Ams 3000m.
| Device ID | K936009 |
| 510k Number | K936009 |
| Device Name: | AMS 3000M |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Contact | Trudi Keller |
| Correspondent | Trudi Keller ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-16 |
| Decision Date | 1995-05-03 |