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FDA 510(k)

CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A

K-Number: K903372 · 1990-11-29

ApplicantShimadzu Medical Systems
Decision Date1990-11-29
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K903372. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A?

CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K903372.

When did CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A receive FDA 510(k) clearance?

CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A received FDA 510(k) clearance on 1990-11-29, under 510(k) number K903372.

Who is the listed applicant for CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A?

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

What is the FDA product code for CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A?

The FDA product code for CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A is IZI.

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Other records listing Shimadzu Medical Systems as applicant

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K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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Related Devices (Code: IZI)

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

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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