LifeShield Infusion Safety Software Suite— 510(k) K223606
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K223606 for LifeShield Infusion Safety Software Suite, Substantially Equivalent on 2023-08-24. Applicant: Icu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Code PHC
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
Recent devices under product code PHC
view allMore clearances from Icu Medical, Inc.
view allRecalls naming K223606
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223606.
Data sourced from openFDA. This site is unofficial and independent of the FDA.