Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K022934 |
Device Name |
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 |
Applicant |
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS |
KRONSAALSWEG 40 |
HAMBURG,
DE
22525
|
|
Applicant Contact |
ECKHARDT ALBERS |
Correspondent |
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS |
KRONSAALSWEG 40 |
HAMBURG,
DE
22525
|
|
Correspondent Contact |
ECKHARDT ALBERS |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/04/2002 |
Decision Date | 11/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|