Device Classification Name |
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
|
510(k) Number |
K951366 |
Device Name |
RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) |
Applicant |
RIKEN KEIKI CO., LTD. |
12318 BIG TREE RD. |
WALES CENTER,
NY
14169 -0201
|
|
Applicant Contact |
ALLAN M BICKFORD |
Correspondent |
RIKEN KEIKI CO., LTD. |
12318 BIG TREE RD. |
WALES CENTER,
NY
14169 -0201
|
|
Correspondent Contact |
ALLAN M BICKFORD |
Regulation Number | 868.1620
|
Classification Product Code |
|
Date Received | 03/27/1995 |
Decision Date | 08/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|