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FDA 510(k)

SW ULTRASOUND, MODELS 331, 311, 333

K-Number: K991613 · 2000-12-08

ApplicantStarbene
Decision Date2000-12-08
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SW ULTRASOUND, MODELS 331, 311, 333 is the device name listed in this FDA 510(k) record. The listed applicant is Starbene. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K991613. 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 SW ULTRASOUND, MODELS 331, 311, 333?

SW ULTRASOUND, MODELS 331, 311, 333 is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Starbene. The 510(k) number is K991613.

When did SW ULTRASOUND, MODELS 331, 311, 333 receive FDA 510(k) clearance?

SW ULTRASOUND, MODELS 331, 311, 333 received FDA 510(k) clearance on 2000-12-08, under 510(k) number K991613.

Who is the listed applicant for SW ULTRASOUND, MODELS 331, 311, 333?

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

What is the FDA product code for SW ULTRASOUND, MODELS 331, 311, 333?

The FDA product code for SW ULTRASOUND, MODELS 331, 311, 333 is IMI.

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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 Starbene 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.

K992099BIO SPA INTELLIGENT

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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