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FDA 510(k)

SITE-RITE 3 ULTRASOUND SYSTEM

K-Number: K993624 · 1999-11-10

ApplicantDymax Corp
Decision Date1999-11-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SITE-RITE 3 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dymax Corp. It received FDA 510(k) clearance on 1999-11-10 under 510(k) number K993624. 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 SITE-RITE 3 ULTRASOUND SYSTEM?

SITE-RITE 3 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Dymax Corp. The 510(k) number is K993624.

When did SITE-RITE 3 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SITE-RITE 3 ULTRASOUND SYSTEM received FDA 510(k) clearance on 1999-11-10, under 510(k) number K993624.

Who is the listed applicant for SITE-RITE 3 ULTRASOUND SYSTEM?

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

What is the FDA product code for SITE-RITE 3 ULTRASOUND SYSTEM?

The FDA product code for SITE-RITE 3 ULTRASOUND SYSTEM is IYO.

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Other records listing Dymax 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.

K032135SITE-RITE IV ULTRASOUND SYSTEMK931403SITERITE NEEDLE GUIDE (MODIFIED)K903158SITERITE NEEDLE GUIDEK894415DYMAX ENDOVAGINAL BIOPSY GUIDEK862127DYMAX PERSONAL SCANNERK850478PLUS 1

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Related Devices (Code: IYO)

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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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