Device Classification Name |
oximeter, tissue saturation
|
510(k) Number |
K012759 |
Device Name |
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 |
Applicant |
HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK |
HUTCHINSON,
MN
55350
|
|
Applicant Contact |
JOSEPH ORTNER |
Correspondent |
HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK |
HUTCHINSON,
MN
55350
|
|
Correspondent Contact |
JOSEPH ORTNER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/17/2001 |
Decision Date | 01/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|