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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K252735
Device Name C-beam
Applicant
Pulmera, Inc.
460 California Ave.
Suite 102
Palo Alto,  CA  94306
Applicant Contact Bryan Hartley
Correspondent
Innovative Product Advocates
803 7th St. NW
Washington DC,  DC  20001
Correspondent Contact Kyle O'Sullivan
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAK  
Date Received08/28/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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