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FDA 510(k)

SONO-VU US(TM)

K-Number: K904583 · 1991-06-24

ApplicantE-Z-Em, Inc.
Decision Date1991-06-24
Product CodeHIO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONO-VU US(TM) is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K904583. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONO-VU US(TM)?

SONO-VU US(TM) is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K904583.

When did SONO-VU US(TM) receive FDA 510(k) clearance?

SONO-VU US(TM) received FDA 510(k) clearance on 1991-06-24, under 510(k) number K904583.

Who is the listed applicant for SONO-VU US(TM)?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONO-VU US(TM)?

The FDA product code for SONO-VU US(TM) is HIO.

Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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Related Devices (Code: HIO)

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.

K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical SystemsK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.K914419AMNIOTEST(TM)Pro-Lab, Inc.K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.

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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