The following data is part of a premarket notification filed by Acutronic Medical Systems Ag with the FDA for Mistral Critical Care Jet Ventilator And Accessories.
Device ID | K012693 |
510k Number | K012693 |
Device Name: | MISTRAL 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 | 2002-08-01 |
Summary: | summary |