Device Classification Name |
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
|
510(k) Number |
K112173 |
Device Name |
SPEACELABS MULTIGAS MODULE |
Applicant |
SPACELABS HEALTHCARE |
P.O. BOX 3018 |
NEDERLAND,
CO
80466
|
|
Applicant Contact |
THOMAS KROENKE |
Correspondent |
SPACELABS HEALTHCARE |
P.O. BOX 3018 |
NEDERLAND,
CO
80466
|
|
Correspondent Contact |
THOMAS KROENKE |
Regulation Number | 868.1700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/28/2011 |
Decision Date | 10/05/2011 |
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
|
|
|