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FDA 510(k)

XUB EXTERNAL ULTRASOUND

K-Number: K010702 · 2001-08-09

ApplicantKmi Kolster Methods, Inc.
Decision Date2001-08-09
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

XUB EXTERNAL ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Kolster Methods, Inc.. It received FDA 510(k) clearance on 2001-08-09 under 510(k) number K010702. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XUB EXTERNAL ULTRASOUND?

XUB EXTERNAL ULTRASOUND is a medical device that received FDA 510(k) clearance on 2001-08-09. The listed applicant is Kmi Kolster Methods, Inc.. The 510(k) number is K010702.

When did XUB EXTERNAL ULTRASOUND receive FDA 510(k) clearance?

XUB EXTERNAL ULTRASOUND received FDA 510(k) clearance on 2001-08-09, under 510(k) number K010702.

Who is the listed applicant for XUB EXTERNAL ULTRASOUND?

The FDA 510(k) record lists Kmi Kolster Methods, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XUB EXTERNAL ULTRASOUND?

The FDA product code for XUB EXTERNAL ULTRASOUND is IMI.

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Other records listing Kmi Kolster Methods, Inc. 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.

K060414KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTUREK043591FEATHERLIFT EXTENDED APTOS THREADK012236STARS2000 POWER CANNULAK002859SSW-STERILE SOLUTION WARMERK991203IRRIGATION OR INFUSION PUMP K PUMP

Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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