Radiopaque Ruler

FDA 510(k) K902606 · Professional Medical Services

Substantially Equivalent

510(k) numberK902606

Submission

Device name
Radiopaque Ruler
Applicant
Professional Medical Services
North Salt Lake, UT, US
Received
June 12, 1990
Decision date
September 27, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Radiopaque Ruler cleared by the FDA?

Radiopaque Ruler (K902606) received a 510(k) decision of Substantially Equivalent on September 27, 1990, 107 days after the submission was received.

What is the product code of K902606?

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