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FDA 510(k)

SONOSITE EDGE ULTRASOUND SYSTEM

K-Number: K113156 · 2011-11-15

ApplicantSonosite,Inc.
Decision Date2011-11-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOSITE EDGE ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonosite,Inc.. It received FDA 510(k) clearance on 2011-11-15 under 510(k) number K113156. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOSITE EDGE ULTRASOUND SYSTEM?

SONOSITE EDGE ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-15. The listed applicant is Sonosite,Inc.. The 510(k) number is K113156.

When did SONOSITE EDGE ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SONOSITE EDGE ULTRASOUND SYSTEM received FDA 510(k) clearance on 2011-11-15, under 510(k) number K113156.

Who is the listed applicant for SONOSITE EDGE ULTRASOUND SYSTEM?

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

What is the FDA product code for SONOSITE EDGE ULTRASOUND SYSTEM?

The FDA product code for SONOSITE EDGE ULTRASOUND SYSTEM is IYO.

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Other records listing Sonosite,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.

K110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITORK102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMK093510LUMENVU CATHETER GUIDANCE SYSTEMK101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEMK092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMK082098SONOSITE MAXX SERIES ULTRASOUND SYSTEM

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Related Devices (Code: IYO)

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K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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