The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Ltv 1000 Ventilator.
| Device ID | K981371 |
| 510k Number | K981371 |
| Device Name: | LTV 1000 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 930 S. MT. VERNON AVE. SUITE 100 Colton, CA 92324 |
| Contact | Douglas Devries |
| Correspondent | Douglas 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 | 1998-04-16 |
| Decision Date | 1998-10-30 |
| Summary: | summary |