The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model Lp6 Ventilator, Modification.
Device ID | K905244 |
510k Number | K905244 |
Device Name: | MODEL LP6 VENTILATOR, MODIFICATION |
Classification | Ventilator, Continuous, Facility Use |
Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
Contact | Kenneth B Herland |
Correspondent | Kenneth B Herland AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-20 |
Decision Date | 1990-11-30 |