The following data is part of a premarket notification filed by Automedx Inc. with the FDA for Save Ii, Save Ii Basic.
| Device ID | K131877 |
| 510k Number | K131877 |
| Device Name: | SAVE II, SAVE II BASIC |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | AUTOMEDX INC. 1420 Lakeside Parkway, Suite 102 Flower Mound, TX 75028 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden AUTOMEDX INC. 1420 Lakeside Parkway, Suite 102 Flower Mound, TX 75028 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90851629008075 | K131877 | 000 |
| 20851629008076 | K131877 | 000 |
| 10851629008079 | K131877 | 000 |
| 00851629008072 | K131877 | 000 |