Device Classification Name |
Conserver, Oxygen
|
510(k) Number |
K010747 |
Device Name |
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 |
Applicant |
WESTERN ENT. |
875 BASSETT RD. |
WESTLAKE,
OH
44145
|
|
Applicant Contact |
BYRON CRAMPTON |
Correspondent |
WESTERN ENT. |
875 BASSETT RD. |
WESTLAKE,
OH
44145
|
|
Correspondent Contact |
BYRON CRAMPTON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/13/2001 |
Decision Date | 05/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|