Device Classification Name |
heater, breathing system w/wo controller (not humidifier or nebulizer
|
510(k) Number |
K151461 |
Device Name |
Hybernite RT |
Applicant |
PLASTIFLEX GROUP NV |
BEVERLOOSESTEENWEG 99 |
PAAL-BERINGEN,
BE
3583
|
|
Applicant Contact |
RAF VAN ROY |
Correspondent |
Qserve Group US, Inc. |
PO BOX 940 |
Charlestown,
NH
03603
|
|
Correspondent Contact |
Patsy J Trisler |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 06/01/2015 |
Decision Date | 03/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|