Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K014074 |
Device Name |
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION |
Applicant |
HOFFRICHTER GMBH |
S65 W35739 PIPER RD. |
EAGLE,
WI
53119
|
|
Applicant Contact |
STEPHEN H GORSKI |
Correspondent |
HOFFRICHTER GMBH |
S65 W35739 PIPER RD. |
EAGLE,
WI
53119
|
|
Correspondent Contact |
STEPHEN H GORSKI |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 12/10/2001 |
Decision Date | 07/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|