Device Classification Name |
Oximeter
|
510(k) Number |
K082546 |
Device Name |
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) |
Applicant |
UNIMED MEDICAL SUPPLIES INC. |
W322S8863 MCCARTHY DR. |
MUKWONAGO,
WI
53149
|
|
Applicant Contact |
DON MELNIKOFF |
Correspondent |
UNIMED MEDICAL SUPPLIES INC. |
W322S8863 MCCARTHY DR. |
MUKWONAGO,
WI
53149
|
|
Correspondent Contact |
DON MELNIKOFF |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/03/2008 |
Decision Date | 12/02/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|