Device Classification Name |
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
|
510(k) Number |
K053599 |
Device Name |
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES |
Applicant |
SPACELABS MEDICAL INC. |
5150 220TH AVE SE |
ISSAQUAH,
WA
98029
|
|
Applicant Contact |
AL VAN HOUDT |
Correspondent |
SPACELABS MEDICAL INC. |
5150 220TH AVE SE |
ISSAQUAH,
WA
98029
|
|
Correspondent Contact |
AL VAN HOUDT |
Regulation Number | 868.1700
|
Classification Product Code |
|
Date Received | 12/23/2005 |
Decision Date | 04/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|