Device Classification Name |
computer, diagnostic, pre-programmed, single-function
|
510(k) Number |
K122247 |
Device Name |
LIDCORAPID V2 MONITOR |
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 |
|
Subsequent Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 03/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|