Device Classification Name |
Oximeter
|
510(k) Number |
K081800 |
Device Name |
T12S TELEMETRY TRANSMITTER |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
LAURA SPIEGELHOFF |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
LAURA SPIEGELHOFF |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/25/2008 |
Decision Date | 09/24/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|