The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Mod. 300 Anesth. Vol. Ventilator W/alarm.
Device ID | K800650 |
510k Number | K800650 |
Device Name: | MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM |
Classification | Ventilator, Continuous, Facility Use |
Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-24 |
Decision Date | 1980-04-02 |