Koala Intrauterine Pressure Catheter (IPC-5000E)— 510(k) K250897
Substantially EquivalentClinical Innovations, LLC
FDA 510(k) clearance K250897 for Koala Intrauterine Pressure Catheter (IPC-5000E), Substantially Equivalent on 2025-05-22. Applicant: Clinical Innovations, LLC.
Clearance details
- Applicant
- Clinical Innovations, LLC
- Product code
- Code HFN
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.