FDA.report

510(k) K252735

Device
C-beam
Applicant
Pulmera, Inc.
510(k) number
K252735
Product code
OWB
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-22
Date received
2025-08-28
Regulation
892.1650
Classification name
Interventional Fluoroscopic X-Ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Bryan Hartley
Address
460 California Ave. Suite 102 Palo Alto CA US 94306 94306

FDA Registration Numbers

Source Documents

510(k) summary PDF

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