Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K041223 |
Device Name |
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
Applicant |
MAQUET CRITICAL CARE AB |
1140 ROUTE 22 EAST |
SUITE 202 |
BRIDGEWATER,
NJ
08807
|
|
Applicant Contact |
JAMIE YIEH |
Correspondent |
MAQUET CRITICAL CARE AB |
1140 ROUTE 22 EAST |
SUITE 202 |
BRIDGEWATER,
NJ
08807
|
|
Correspondent Contact |
JAMIE YIEH |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 07/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|