FDA 510(k)

PSI 220 DUAL EMG

K-Number: K925197 · 1993-02-02

Decision Date1993-02-02

Product CodeHCC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PSI 220 DUAL EMG is the device name listed in this FDA 510(k) record. The listed applicant is Fasstech. It received FDA 510(k) clearance on 1993-02-02 under 510(k) number K925197. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSI 220 DUAL EMG?

PSI 220 DUAL EMG is a medical device that received FDA 510(k) clearance on 1993-02-02. The listed applicant is Fasstech. The 510(k) number is K925197.

When did PSI 220 DUAL EMG receive FDA 510(k) clearance?

PSI 220 DUAL EMG received FDA 510(k) clearance on 1993-02-02, under 510(k) number K925197.

Who is the listed applicant for PSI 220 DUAL EMG?

The FDA 510(k) record lists Fasstech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSI 220 DUAL EMG?

The FDA product code for PSI 220 DUAL EMG is HCC.

Other records listing Fasstech as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.