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FDA 510(k)

SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.

K-Number: K885349 · 1989-06-22

ApplicantSonotek Corp.
Decision Date1989-06-22
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. is the device name listed in this FDA 510(k) record. The listed applicant is Sonotek Corp.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K885349. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.?

SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Sonotek Corp.. The 510(k) number is K885349.

When did SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. receive FDA 510(k) clearance?

SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. received FDA 510(k) clearance on 1989-06-22, under 510(k) number K885349.

Who is the listed applicant for SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.?

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

What is the FDA product code for SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.?

The FDA product code for SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. is DXK.

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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