The following data is part of a premarket notification filed by Ge Healthcare, Breas Medical Ab with the FDA for Vivo 50.
| Device ID | K123144 |
| 510k Number | K123144 |
| Device Name: | VIVO 50 |
| Classification | Continuous, Ventilator, Home Use |
| Applicant | GE HEALTHCARE, BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 435 33 |
| Contact | Shlomi Deler |
| Correspondent | Shlomi Deler GE HEALTHCARE, BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 435 33 |
| Product Code | NOU |
| Subsequent Product Code | CBK |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2013-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07321822151163 | K123144 | 000 |
| 07321820046683 | K123144 | 000 |
| 07321820046676 | K123144 | 000 |
| 07321820049011 | K123144 | 000 |
| 07321820048991 | K123144 | 000 |
| 07321820048984 | K123144 | 000 |
| 07321820048977 | K123144 | 000 |
| 07321820048960 | K123144 | 000 |
| 07321820048946 | K123144 | 000 |
| 07321820048939 | K123144 | 000 |
| 07321820048922 | K123144 | 000 |
| 07321820048915 | K123144 | 000 |
| 07321820048861 | K123144 | 000 |
| 07321820045594 | K123144 | 000 |
| 07321820049394 | K123144 | 000 |
| 07321820050321 | K123144 | 000 |
| 07321820050369 | K123144 | 000 |
| 07321822150166 | K123144 | 000 |
| 07321822150005 | K123144 | 000 |
| 07321820072194 | K123144 | 000 |
| 07321820067084 | K123144 | 000 |
| 07321820063444 | K123144 | 000 |
| 07321820059287 | K123144 | 000 |
| 07321820054299 | K123144 | 000 |
| 07321820054282 | K123144 | 000 |
| 07321820052233 | K123144 | 000 |
| 07321820051892 | K123144 | 000 |
| 07321820051007 | K123144 | 000 |
| 07321820050949 | K123144 | 000 |
| 07321820050666 | K123144 | 000 |
| 07321820021857 | K123144 | 000 |