Simplamatic III

FDA 510(k) K827450 · Spectrum X-Ray Corp.

Substantially Equivalent

510(k) numberK827450

Submission

Device name
Simplamatic III
Applicant
Spectrum X-Ray Corp.
Westville, NJ, US
Received
April 27, 1982
Decision date
May 19, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was Simplamatic III cleared by the FDA?

Simplamatic III (K827450) received a 510(k) decision of Substantially Equivalent on May 19, 1982, 22 days after the submission was received.