Philips BV 300 Series

FDA 510(k) K953910 · Philips Medical Systems North America, Inc.

Substantially Equivalent

510(k) numberK953910

Submission

Device name
Philips BV 300 Series
Applicant
Philips Medical Systems North America, Inc.
Shelton, CT, US
Received
August 21, 1995
Decision date
October 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Fluoroscopy of the human body.

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Questions and answers

When was Philips BV 300 Series cleared by the FDA?

Philips BV 300 Series (K953910) received a 510(k) decision of Substantially Equivalent on October 18, 1995, 58 days after the submission was received.

What is the product code of K953910?

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