PORTABLE BREAST COMPRESSION DEVICE— 510(k) K003775

Substantially Equivalent

Pem Technologies

FDA 510(k) clearance K003775 for PORTABLE BREAST COMPRESSION DEVICE, Substantially Equivalent on 2001-01-12. Applicant: Pem Technologies.

Clearance details

Applicant: Pem Technologies
Product code: Code IYX
Advisory panel: Radiology
Date received: 2000-12-06
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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