510(k) K242295

Device
BunkerHill BMD
Applicant
BunkerHill Health
510(k) number
K242295
Product code
KGI
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-08
Date received
2024-08-02
Regulation
892.1170
Classification name
Densitometer, Bone
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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