Device Classification Name |
oximeter, reprocessed
|
510(k) Number |
K111773 |
FOIA Releasable 510(k) |
K111773
|
Device Name |
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE |
Applicant |
RENU MEDICAL, INC. |
9800 EVERGREEN WAY |
EVERETT,
WA
98204
|
|
Applicant Contact |
L BRUCE PIERSON |
Correspondent |
RENU MEDICAL, INC. |
9800 EVERGREEN WAY |
EVERETT,
WA
98204
|
|
Correspondent Contact |
L BRUCE PIERSON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/23/2011 |
Decision Date | 11/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|