The following data is part of a premarket notification filed by Automedx Inc. with the FDA for Save-simplified Automated Ventilator, Models: 550x10, 600x10 And 600x12.
| Device ID | K071221 |
| 510k Number | K071221 |
| Device Name: | SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | AUTOMEDX INC. 12321 MIDDLEBROOK RD SUITE 150 Germantown, MD 20874 |
| Contact | James D Evans |
| Correspondent | James D Evans AUTOMEDX INC. 12321 MIDDLEBROOK RD SUITE 150 Germantown, MD 20874 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-02 |
| Decision Date | 2007-09-06 |
| Summary: | summary |