Device Classification Name |
Oximeter, Ear
|
510(k) Number |
K810363 |
Device Name |
EAR OXIMETER |
Applicant |
BIO-TEK INSTRUMENTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BIO-TEK INSTRUMENTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.2710
|
Classification Product Code |
|
Date Received | 02/11/1981 |
Decision Date | 02/27/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|