The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Ventilator, Continuous (respirator), Model Ltv 1000.
| Device ID | K002881 |
| 510k Number | K002881 |
| Device Name: | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 930 SOUTH MT. VERNON AVE., SUITE 100 Colton, CA 92324 -3928 |
| Contact | Robert Hankins |
| Correspondent | Robert Hankins PULMONETIC SYSTEMS, INC. 930 SOUTH MT. VERNON AVE., SUITE 100 Colton, CA 92324 -3928 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-15 |
| Decision Date | 2000-10-11 |