Device Classification Name |
Oximeter
|
510(k) Number |
K964978 |
Device Name |
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) |
Applicant |
QUINTON, INC. |
3303 MONTE VILLA PKWY. |
BOTHELL,
WA
98021 -8906
|
|
Applicant Contact |
MATTHEW HEDLUND |
Correspondent |
QUINTON, INC. |
3303 MONTE VILLA PKWY. |
BOTHELL,
WA
98021 -8906
|
|
Correspondent Contact |
MATTHEW HEDLUND |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/12/1996 |
Decision Date | 05/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|