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FDA 510(k)

BIPHASIC UNIT

K-Number: K923498 · 1993-03-04

ApplicantWillows Health Center
Decision Date1993-03-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIPHASIC 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 K923498. 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 BIPHASIC UNIT?

BIPHASIC 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 K923498.

When did BIPHASIC UNIT receive FDA 510(k) clearance?

BIPHASIC UNIT received FDA 510(k) clearance on 1993-03-04, under 510(k) number K923498.

Who is the listed applicant for BIPHASIC 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 BIPHASIC UNIT?

The FDA product code for BIPHASIC UNIT is IPF.

Related Clinical Trials

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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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.

K923501HIGH VOLT UNIT

Related Devices (Code: IPF)

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.

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