The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Rateminder V Infusion Pump W/secondary Capability.
Device ID | K902092 |
510k Number | K902092 |
Device Name: | RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY |
Classification | Pump, Infusion |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Contact | S Samorajczyk |
Correspondent | S Samorajczyk CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-09 |
Decision Date | 1990-07-26 |