The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Palmtop Ventilator, Models Ptv-8, Ptv-10.
| Device ID | K070594 |
| 510k Number | K070594 |
| Device Name: | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 17400 MEDINA ROAD SUITE 100 Minneapolis, MN 55447 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec PULMONETIC SYSTEMS, INC. 17400 MEDINA ROAD SUITE 100 Minneapolis, MN 55447 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-02 |
| Decision Date | 2007-08-01 |
| Summary: | summary |