Device Classification Name |
oximeter
|
510(k) Number |
K061191 |
Device Name |
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 |
Applicant |
MEASUREMENT SPECIALTIES, INC. |
2300 MCDERMOTT ROAD |
# 200-207 |
PLANO,
TX
75025
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
MEASUREMENT SPECIALTIES, INC. |
2300 MCDERMOTT ROAD |
# 200-207 |
PLANO,
TX
75025
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/28/2006 |
Decision Date | 05/22/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|