Device Classification Name |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
|
510(k) Number |
K034026 |
Device Name |
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
AUCKLAND,
NZ
1701
|
|
Applicant Contact |
ADELE BINDON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
AUCKLAND,
NZ
1701
|
|
Correspondent Contact |
ADELE BINDON |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 12/29/2003 |
Decision Date | 01/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|