Real-Time Spectrum Analyzer

FDA 510(k) K830628 · Diagnostic Electronics Corp.

Substantially Equivalent

510(k) numberK830628

Submission

Device name
Real-Time Spectrum Analyzer
Applicant
Diagnostic Electronics Corp.
Mchenry, IL, US
Received
March 1, 1983
Decision date
June 2, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1435
Specialty
Cardiovascular

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More from Lidco, Ltd.

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Questions and answers

When was Real-Time Spectrum Analyzer cleared by the FDA?

Real-Time Spectrum Analyzer (K830628) received a 510(k) decision of Substantially Equivalent on June 2, 1983, 93 days after the submission was received.

What is the product code of K830628?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.