FDA 510(k)

ULTRASOUND SCANNER, MODEL TYPE 2101

K-Number: K991937 · 1999-07-30

Decision Date1999-07-30

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER, MODEL TYPE 2101 is the device name listed in this FDA 510(k) record. The listed applicant is B & K Medical A/S. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991937. 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 ULTRASOUND SCANNER, MODEL TYPE 2101?

ULTRASOUND SCANNER, MODEL TYPE 2101 is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is B & K Medical A/S. The 510(k) number is K991937.

When did ULTRASOUND SCANNER, MODEL TYPE 2101 receive FDA 510(k) clearance?

ULTRASOUND SCANNER, MODEL TYPE 2101 received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991937.

Who is the listed applicant for ULTRASOUND SCANNER, MODEL TYPE 2101?

The FDA 510(k) record lists B & K Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER, MODEL TYPE 2101?

The FDA product code for ULTRASOUND SCANNER, MODEL TYPE 2101 is IYO.

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Other records listing B & K Medical A/S as applicant

K002085ULTRASOUND SCANNER, TYPE 1101 K000567ULTRASOUND SCANNER TYPE 2102 K936024ULTRASOUND SCANNER 2001

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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.