Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K080175 |
Device Name |
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 |
Applicant |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Applicant Contact |
KATHLEEN KRAMER |
Correspondent |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Correspondent Contact |
KATHLEEN KRAMER |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 01/24/2008 |
Decision Date | 06/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|