Device Classification Name |
Computer, Diagnostic, Pre-Programmed, Single-Function
|
510(k) Number |
K023960 |
Device Name |
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 |
Applicant |
LIDCO LTD. |
16 ORSMAN RD. |
LONDON,
GB
N15QJ
|
|
Applicant Contact |
GREGORY SPELLER |
Correspondent |
LIDCO LTD. |
16 ORSMAN RD. |
LONDON,
GB
N15QJ
|
|
Correspondent Contact |
GREGORY SPELLER |
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 11/29/2002 |
Decision Date | 01/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|