SR Suite 1.0

FDA 510(k) K121345 · Halifax Biomedical, Inc.

Substantially Equivalent

510(k) numberK121345

Submission

Device name
SR Suite 1.0
Applicant
Halifax Biomedical, Inc.
Naples, FL, US
Received
May 4, 2012
Decision date
June 1, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPR – System, X-Ray, Stationary
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

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Questions and answers

When was SR Suite 1.0 cleared by the FDA?

SR Suite 1.0 (K121345) received a 510(k) decision of Substantially Equivalent on June 1, 2012, 28 days after the submission was received.

What is the product code of K121345?

The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.