The following data is part of a premarket notification filed by Acutronic Medical Systems Ag with the FDA for Heated Jet Humidifier Model Ams-1020.
| Device ID | K863154 |
| 510k Number | K863154 |
| Device Name: | HEATED JET HUMIDIFIER MODEL AMS-1020 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Contact | Ajai Singh |
| Correspondent | Ajai Singh ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-15 |
| Decision Date | 1987-01-12 |