The following data is part of a premarket notification filed by O-two Systems International Inc. with the FDA for Smart Bag Mo.
| Device ID | K021328 |
| 510k Number | K021328 |
| Device Name: | SMART BAG MO |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL ST. Mississauga,ontario, CA L5s 1c8 |
| Contact | Kevin Bowden |
| Correspondent | Kevin Bowden O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL ST. Mississauga,ontario, CA L5s 1c8 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-26 |
| Decision Date | 2003-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540195000220 | K021328 | 000 |
| 17540195000480 | K021328 | 000 |
| 17540195000497 | K021328 | 000 |
| 07540195000025 | K021328 | 000 |
| 07540195000063 | K021328 | 000 |
| 17540195000084 | K021328 | 000 |
| 17540195000107 | K021328 | 000 |
| 07540195000124 | K021328 | 000 |
| 17540195000145 | K021328 | 000 |
| 07540195000162 | K021328 | 000 |
| 07540195000186 | K021328 | 000 |
| 17540195000206 | K021328 | 000 |
| 17540195000237 | K021328 | 000 |