Device Classification Name |
analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
|
510(k) Number |
K040188 |
Device Name |
INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE |
Applicant |
Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Applicant Contact |
PENELOPE H GRECO |
Correspondent |
Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
PENELOPE H GRECO |
Regulation Number | 868.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/28/2004 |
Decision Date | 04/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|