Device Classification Name |
oximeter
|
510(k) Number |
K933519 |
Device Name |
INDEX SPO2 SIMULATOR |
Applicant |
BIO-TEK INSTRUMENTS, INC. |
HIGHLAND PARK |
P.O. BOX 998 |
WINOOSKI,
VT
05404 -0998
|
|
Applicant Contact |
MICHAEL N SEVIGNY |
Correspondent |
BIO-TEK INSTRUMENTS, INC. |
HIGHLAND PARK |
P.O. BOX 998 |
WINOOSKI,
VT
05404 -0998
|
|
Correspondent Contact |
MICHAEL N SEVIGNY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/20/1993 |
Decision Date | 09/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|