Device Classification Name |
Oximeter, Tissue Saturation
|
510(k) Number |
K053618 |
Device Name |
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 |
Applicant |
HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK |
HUTCHINSON,
MN
55350
|
|
Applicant Contact |
JOSEPH P ORTNER |
Correspondent |
HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK |
HUTCHINSON,
MN
55350
|
|
Correspondent Contact |
JOSEPH P ORTNER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/28/2005 |
Decision Date | 02/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|