The following data is part of a premarket notification filed by Lidco Ltd. with the FDA for Lidcorapid V2 Monitor.
Device ID | K122247 |
510k Number | K122247 |
Device Name: | LIDCORAPID V2 MONITOR |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | LIDCO LTD. 16 ORSMAN RD. London, GB N15qj |
Contact | Gregory Speller |
Correspondent | Gregory Speller LIDCO LTD. 16 ORSMAN RD. London, GB N15qj |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-27 |
Decision Date | 2013-03-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060110522927 | K122247 | 000 |
05060110521562 | K122247 | 000 |
05060110521548 | K122247 | 000 |
05060110521531 | K122247 | 000 |
05060110521494 | K122247 | 000 |
05060110521401 | K122247 | 000 |
05060110520923 | K122247 | 000 |
05060110520893 | K122247 | 000 |
05060110520848 | K122247 | 000 |
05060110520831 | K122247 | 000 |
05060110521579 | K122247 | 000 |
05060110521586 | K122247 | 000 |
05060110521845 | K122247 | 000 |
05060110522620 | K122247 | 000 |
05060110522613 | K122247 | 000 |
05060110522194 | K122247 | 000 |
05060110522187 | K122247 | 000 |
05060110522125 | K122247 | 000 |
05060110522064 | K122247 | 000 |
05060110522057 | K122247 | 000 |
05060110522040 | K122247 | 000 |
05060110521968 | K122247 | 000 |
05060110520824 | K122247 | 000 |