FDA 510(k)

HIGH VOLT UNIT

K-Number: K923501 · 1993-03-04

Decision Date1993-03-04

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HIGH VOLT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Willows Health Center. It received FDA 510(k) clearance on 1993-03-04 under 510(k) number K923501. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH VOLT UNIT?

HIGH VOLT UNIT is a medical device that received FDA 510(k) clearance on 1993-03-04. The listed applicant is Willows Health Center. The 510(k) number is K923501.

When did HIGH VOLT UNIT receive FDA 510(k) clearance?

HIGH VOLT UNIT received FDA 510(k) clearance on 1993-03-04, under 510(k) number K923501.

Who is the listed applicant for HIGH VOLT UNIT?

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

What is the FDA product code for HIGH VOLT UNIT?

The FDA product code for HIGH VOLT UNIT is IPF.

Other records listing Willows Health Center 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.

K923498BIPHASIC UNIT

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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.