The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Modification To Ltv 1000 Ventilator/breathing Circuits.
| Device ID | K040790 |
| 510k Number | K040790 |
| Device Name: | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 17400 MEDINA RD. SUITE 100 Minneapolis, MN 55447 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec PULMONETIC SYSTEMS, INC. 17400 MEDINA RD. SUITE 100 Minneapolis, MN 55447 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-06-03 |
| Summary: | summary |