P1310 Automatic Brightness Stabilizer (Abs)

FDA 510(k) K915405 · Precise Optics Photo Medic Equipment, Inc.

Substantially Equivalent

510(k) numberK915405

Submission

Device name
P1310 Automatic Brightness Stabilizer (Abs)
Applicant
Precise Optics Photo Medic Equipment, Inc.
Bay Shore, NY, US
Received
December 2, 1991
Decision date
February 4, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

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Questions and answers

When was P1310 Automatic Brightness Stabilizer (Abs) cleared by the FDA?

P1310 Automatic Brightness Stabilizer (Abs) (K915405) received a 510(k) decision of Substantially Equivalent on February 4, 1992, 64 days after the submission was received.

What is the product code of K915405?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.