General Electric Panelipse LD

FDA 510(k) K792581 · General Electric Co.

Substantially Equivalent

510(k) numberK792581

Submission

Device name
General Electric Panelipse LD
Applicant
General Electric Co.
Mchenry, IL, US
Received
December 14, 1979
Decision date
January 16, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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Questions and answers

When was General Electric Panelipse LD cleared by the FDA?

General Electric Panelipse LD (K792581) received a 510(k) decision of Substantially Equivalent on January 16, 1980, 33 days after the submission was received.

What is the product code of K792581?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.