The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Modification To Lap Top Ventilator (ltv).
| Device ID | K010608 |
| 510k Number | K010608 |
| Device Name: | MODIFICATION TO LAP TOP VENTILATOR (LTV) |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 930 SOUTH MT. VERNON AVE., SUITE 100 Colton, CA 92324 -3928 |
| Contact | Darryl Shelby |
| Correspondent | Darryl Shelby PULMONETIC SYSTEMS, INC. 930 SOUTH MT. VERNON AVE., SUITE 100 Colton, CA 92324 -3928 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-01 |
| Decision Date | 2001-03-20 |