The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Ltv 1200 Ventilator.
| Device ID | K060647 |
| 510k Number | K060647 |
| Device Name: | LTV 1200 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 17400 MEDINA ROAD SUITE 100 Minneapolis, MN 55447 |
| Contact | Robert Samec |
| Correspondent | Robert 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 | 2006-03-13 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752190368 | K060647 | 000 |
| 10190752188808 | K060647 | 000 |
| 10190752188761 | K060647 | 000 |
| 10190752188754 | K060647 | 000 |
| 10190752130364 | K060647 | 000 |