Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K122075 |
Device Name |
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER |
Applicant |
INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. |
LIVERPOOL,
NY
13088
|
|
Applicant Contact |
MICHAEL ZALEEWSKI |
Correspondent |
INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. |
LIVERPOOL,
NY
13088
|
|
Correspondent Contact |
MICHAEL ZALEEWSKI |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 12/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|