Spectra ECG

FDA 510(k) K915658 · Advanced Medical Products, Inc.

Substantially Equivalent

510(k) numberK915658

Submission

Device name
Spectra ECG
Applicant
Advanced Medical Products, Inc.
Liverpool, NY, US
Received
December 18, 1991
Decision date
June 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was Spectra ECG cleared by the FDA?

Spectra ECG (K915658) received a 510(k) decision of Substantially Equivalent on June 10, 1992, 175 days after the submission was received.