The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Ltv 1000.
| Device ID | K984056 |
| 510k Number | K984056 |
| Device Name: | LTV 1000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 930 S. MT. VERNON AVE. SUITE 100 Colton, CA 92324 |
| Contact | Douglas F Devries |
| Correspondent | Douglas F Devries PULMONETIC SYSTEMS, INC. 930 S. MT. VERNON AVE. SUITE 100 Colton, CA 92324 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-13 |
| Decision Date | 1999-04-12 |
| Summary: | summary |