The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model Lp-1000 Volume Ventilator.
| Device ID | K952880 |
| 510k Number | K952880 |
| Device Name: | MODEL LP-1000 VOLUME VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-22 |
| Decision Date | 1996-06-20 |