The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Var-plus (vortran Automatic Resuscitator), Model Pcm.
| Device ID | K041473 |
| 510k Number | K041473 |
| Device Name: | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 1804 TRIBUTE RD., SUITE F Sacramento, CA 95815 |
| Contact | James Lee |
| Correspondent | James Lee VORTRAN MEDICAL TECHNOLOGY 1, INC. 1804 TRIBUTE RD., SUITE F Sacramento, CA 95815 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-02 |
| Decision Date | 2004-07-15 |
| Summary: | summary |