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. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, LLC
- Product code
- Code HFN
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
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