The following data is part of a premarket notification filed by O-two Medical Technologies, Inc. with the FDA for O-two E700,o-two E600,o-two E500.
| Device ID | K141595 |
| 510k Number | K141595 |
| Device Name: | O-TWO E700,O-TWO E600,O-TWO E500 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Contact | David Zhang |
| Correspondent | David Zhang O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2015-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540195033054 | K141595 | 000 |
| 07540195033030 | K141595 | 000 |
| 07540195033009 | K141595 | 000 |