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FDA 510(k)

BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC

K-Number: K052987 · 2005-11-08

ApplicantNoras Rontgen-Und Medizintechnik GmbH
Decision Date2005-11-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC is the device name listed in this FDA 510(k) record. The listed applicant is Noras Rontgen-Und Medizintechnik GmbH. It received FDA 510(k) clearance on 2005-11-08 under 510(k) number K052987. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC?

BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC is a medical device that received FDA 510(k) clearance on 2005-11-08. The listed applicant is Noras Rontgen-Und Medizintechnik GmbH. The 510(k) number is K052987.

When did BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC receive FDA 510(k) clearance?

BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC received FDA 510(k) clearance on 2005-11-08, under 510(k) number K052987.

Who is the listed applicant for BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC?

The FDA 510(k) record lists Noras Rontgen-Und Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC?

The FDA product code for BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC is LNH.

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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.

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