The following data is part of a premarket notification filed by Acutronic Medical Systems Ag with the FDA for Universal Jet Ventilator Model Ams-1000.
| Device ID | K863155 |
| 510k Number | K863155 |
| Device Name: | UNIVERSAL JET VENTILATOR MODEL AMS-1000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Contact | Ajai Sinh |
| Correspondent | Ajai Sinh ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-15 |
| Decision Date | 1987-09-28 |