Device Classification Name |
oximeter
|
510(k) Number |
K971235 |
Device Name |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W |
Applicant |
ALEXANDER MFG. CO. |
1511 S GARFIELD PL |
MASON CITY,
IA
50401
|
|
Applicant Contact |
KEN HEIMENDINGER |
Correspondent |
ALEXANDER MFG. CO. |
1511 S GARFIELD PL |
MASON CITY,
IA
50401
|
|
Correspondent Contact |
KEN HEIMENDINGER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/02/1997 |
Decision Date | 06/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|