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FDA 510(k)

SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

K-Number: K070779 · 2008-07-09

ApplicantMisonix, Inc.
Decision Date2008-07-09
Product CodeNTB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Misonix, Inc.. It received FDA 510(k) clearance on 2008-07-09 under 510(k) number K070779. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM?

SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-09. The listed applicant is Misonix, Inc.. The 510(k) number is K070779.

When did SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM receive FDA 510(k) clearance?

SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM received FDA 510(k) clearance on 2008-07-09, under 510(k) number K070779.

Who is the listed applicant for SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM?

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

What is the FDA product code for SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM?

The FDA product code for SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM is NTB.

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Other records listing Misonix, Inc. as applicant

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K221235neXus Ultrasonic Surgical Aspirator SystemK212060neXus Ultrasonic Surgical Aspirator SystemK190160neXus Ultrasonic Surgical Aspirator SystemK123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESK112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESK070313MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

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Related Devices (Code: NTB)

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.

K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.K060346ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEMUltrazonix Dnt ABK042096MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEMMisonix, Inc.K040641ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1Epicor Medical, Inc.K022894EPICOR MEDICAL ABLATION SYSTEMEpicor Medical, Inc.

Official Source

View on FDA Database →

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

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