Cathode Ray Tube Med. Display

FDA 510(k) K781256 · Rae Medical Corp.

Substantially Equivalent

510(k) numberK781256

Submission

Device name
Cathode Ray Tube Med. Display
Applicant
Rae Medical Corp.
Mchenry, IL, US
Received
July 21, 1978
Decision date
September 20, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXJ – Display, Cathode-Ray Tube, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2450
Specialty
Cardiovascular

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More from Barco N.V.

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Questions and answers

When was Cathode Ray Tube Med. Display cleared by the FDA?

Cathode Ray Tube Med. Display (K781256) received a 510(k) decision of Substantially Equivalent on September 20, 1978, 61 days after the submission was received.

What is the product code of K781256?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.