FDA 510(k) Applications for Medical Device:
Continuous, Ventilator, Home Use
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K233452 | Breas Medical AB |
Foretagsvagen 1 | Molnlycke | SE-453 33 | |
| K193586 | Breas Medical AB |
Foretagsvagen 1 | Molnlyeke | SE-453 33 | |
| K160481 | BREAS MEDICAL AB |
FORETAGSVAGEN 1 | MOLNLYCKE VASTRA GOTALANDS LAN | 435 33 | |
| K123144 | GE HEALTHCARE, BREAS MEDICAL AB |
FORETAGSVAGEN 1 | MOLNLYCKE | 435 33 | |
| K022750 | RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. | CARLSBAD | CA | 92009 |
| K034032 | RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. | CARLSBAD | CA | 92009 |
| K021981 | VERSAMED LTD. |
P.O.B. 5011, ORNAT BLDG. | KADIMA | 60920 |
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