The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Automobile Lighter Power Cord.
| Device ID | K060549 |
| 510k Number | K060549 |
| Device Name: | AUTOMOBILE LIGHTER POWER CORD |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PULMONETIC SYSTEMS, INC. 117400 MEDINA RD. SUITE 100 Minneapolis, MN 55447 -1341 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec PULMONETIC SYSTEMS, INC. 117400 MEDINA RD. SUITE 100 Minneapolis, MN 55447 -1341 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-02 |
| Decision Date | 2006-05-04 |
| Summary: | summary |