The following data is part of a premarket notification filed by Acutronic Medical Systems Ag with the FDA for Monsoon Critical Care Jet Ventilator And Accessories.
| Device ID | K012691 |
| 510k Number | K012691 |
| Device Name: | MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | ACUTRONIC MEDICAL SYSTEMS AG PO BOX 85820 Tucson, AZ 85754 -5820 |
| Contact | Terry Torzala |
| Correspondent | Terry Torzala ACUTRONIC MEDICAL SYSTEMS AG PO BOX 85820 Tucson, AZ 85754 -5820 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2002-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640140861616 | K012691 | 000 |