The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Rateminder(tm) V Infusion Pump, Modification.
Device ID | K911769 |
510k Number | K911769 |
Device Name: | RATEMINDER(TM) V INFUSION PUMP, MODIFICATION |
Classification | Pump, Infusion |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Contact | John Matson |
Correspondent | John Matson 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 | 1991-04-19 |
Decision Date | 1991-06-03 |