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FDA 510(k)

240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS

K-Number: K003725 · 2001-03-01

ApplicantPie Medical
Decision Date2001-03-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K003725. 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 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS?

240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Pie Medical. The 510(k) number is K003725.

When did 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS receive FDA 510(k) clearance?

240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS received FDA 510(k) clearance on 2001-03-01, under 510(k) number K003725.

Who is the listed applicant for 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS?

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

What is the FDA product code for 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS?

The FDA product code for 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS is IYO.

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Other records listing Pie Medical 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.

K061961ART LAB SOFTWAREK053154MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEMK043588MYLAB 15 / MYLAB 20, MODEL 2700K043360IMT.LABK041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSK033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

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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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