The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Respirtech Pro-o2c, Model 2200 And Respirtech Pro, Model 2000.
| Device ID | K001430 |
| 510k Number | K001430 |
| Device Name: | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST. SUITE 354 Sacramento, CA 95819 |
| Contact | Gordon A Wong |
| Correspondent | Gordon A Wong VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST. SUITE 354 Sacramento, CA 95819 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-05 |
| Decision Date | 2000-07-05 |