PORTABLE BREAST COMPRESSION DEVICE— 510(k) K003775

Name: FDA 510(k) clearance K003775
Creator: U.S. Food and Drug Administration
Published: 2001-01-12

Substantially Equivalent

Pem Technologies

FDA 510(k) clearance K003775 for PORTABLE BREAST COMPRESSION DEVICE, Substantially Equivalent on 2001-01-12. Applicant: Pem Technologies. Device class: 1.

Clearance details

Applicant: Pem Technologies
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2000-12-06
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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