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FDA 510(k)

PR3 ULTRASOUND SYSTEM

K-Number: K993978 · 2000-02-10

ApplicantCarolina Medical, Inc.
Decision Date2000-02-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PR3 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical, Inc.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K993978. 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 PR3 ULTRASOUND SYSTEM?

PR3 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Carolina Medical, Inc.. The 510(k) number is K993978.

When did PR3 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

PR3 ULTRASOUND SYSTEM received FDA 510(k) clearance on 2000-02-10, under 510(k) number K993978.

Who is the listed applicant for PR3 ULTRASOUND SYSTEM?

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

What is the FDA product code for PR3 ULTRASOUND SYSTEM?

The FDA product code for PR3 ULTRASOUND 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.

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Other records listing Carolina Medical, 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.

K050324INFPUMP INFILTRATION PUMP

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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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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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