The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Continuous Volume Ventilator Model Lp10.
| Device ID | K903010 |
| 510k Number | K903010 |
| Device Name: | CONTINUOUS VOLUME VENTILATOR MODEL LP10 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Kenneth Herland |
| Correspondent | Kenneth 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 | 1990-07-11 |
| Decision Date | 1990-11-30 |