The following data is part of a premarket notification filed by Universal Medical Technologies with the FDA for Eureka Infusion Pump, Models Eureka-ip, Eureka-lf.
Device ID | K052817 |
510k Number | K052817 |
Device Name: | EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF |
Classification | Pump, Infusion |
Applicant | UNIVERSAL MEDICAL TECHNOLOGIES PO BOX 5155 Larkspur, CA 94977 -5155 |
Contact | Glenn Herskowitz |
Correspondent | Glenn Herskowitz UNIVERSAL MEDICAL TECHNOLOGIES PO BOX 5155 Larkspur, CA 94977 -5155 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-04 |
Decision Date | 2006-04-17 |
Summary: | summary |