Device Classification Name |
Set, I.V. Fluid Transfer
|
510(k) Number |
K243985 |
Device Name |
Rio™ Drug Reconstitution Transfer Device |
Applicant |
ICU Medical, Inc. |
951 Calle Amanecer |
San Clemente,
CA
92673
|
|
Applicant Contact |
Michelle Doherty |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/23/2024 |
Decision Date | 01/22/2025 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|