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FDA 510(k)

SONOPSY LA SYSTEM

K-Number: K980423 · 1998-08-07

Decision Date1998-08-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOPSY LA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neovision Corp.. It received FDA 510(k) clearance on 1998-08-07 under 510(k) number K980423. 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 SONOPSY LA SYSTEM?

SONOPSY LA SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Neovision Corp.. The 510(k) number is K980423.

When did SONOPSY LA SYSTEM receive FDA 510(k) clearance?

SONOPSY LA SYSTEM received FDA 510(k) clearance on 1998-08-07, under 510(k) number K980423.

Who is the listed applicant for SONOPSY LA SYSTEM?

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

What is the FDA product code for SONOPSY LA SYSTEM?

The FDA product code for SONOPSY LA SYSTEM is IYO.

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.

Other records listing Neovision Corp. 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.

Related Devices (Code: IYO)

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.

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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