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FDA 510(k)

FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT

K-Number: K050320 · 2005-08-15

ApplicantAscendia Medtech AB
Decision Date2005-08-15
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ascendia Medtech AB. It received FDA 510(k) clearance on 2005-08-15 under 510(k) number K050320. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT?

FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT is a medical device that received FDA 510(k) clearance on 2005-08-15. The listed applicant is Ascendia Medtech AB. The 510(k) number is K050320.

When did FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT receive FDA 510(k) clearance?

FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT received FDA 510(k) clearance on 2005-08-15, under 510(k) number K050320.

Who is the listed applicant for FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT?

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

What is the FDA product code for FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT?

The FDA product code for FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT is ITX.

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Related Devices (Code: ITX)

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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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