FDA 510(k)

BREAST-BOARD (MULTIPLE)

K-Number: K003778 · 2001-06-08

Decision Date2001-06-08

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BREAST-BOARD (MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Arplay Medical S.A.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K003778. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST-BOARD (MULTIPLE)?

BREAST-BOARD (MULTIPLE) is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Arplay Medical S.A.. The 510(k) number is K003778.

When did BREAST-BOARD (MULTIPLE) receive FDA 510(k) clearance?

BREAST-BOARD (MULTIPLE) received FDA 510(k) clearance on 2001-06-08, under 510(k) number K003778.

Who is the listed applicant for BREAST-BOARD (MULTIPLE)?

The FDA 510(k) record lists Arplay Medical S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREAST-BOARD (MULTIPLE)?

The FDA product code for BREAST-BOARD (MULTIPLE) is IYE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.