High Flow Insufflation Unit (UHI-4)
Olympus Medical Systems Corporation · K243527
FDA-authorized Predetermined Change Control Plan
- Company
- Olympus Medical Systems Corporation
- 510(k)/De Novo #
- K243527
- Decision date
- 2025-01-13
- Panel
- Obstetrics/Gynecology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Unknown
- Monitoring commitment
- Unknown
Other Obstetrics/Gynecology PCCPs
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We read the PCCP for High Flow Insufflation Unit (UHI-4), then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
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