FDA.report

510(k) K250662

Device
Bunkerhill MAC
Applicant
BunkerHill Health
510(k) number
K250662
Product code
JAK
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-03
Date received
2025-03-05
Regulation
892.1750
Classification name
System, X-Ray, Tomography, Computed
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
Nishith Khandwala
Address
436 Bryant St. San Francisco CA US 94107 94107

FDA Registration Numbers

Source Documents

510(k) summary PDF

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