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FDA 510(k)

BREAST IMMOBILIZATION DEVICE MR-BY 160

K-Number: K001303 · 2000-06-20

ApplicantMri Devices Corp.
Decision Date2000-06-20
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BREAST IMMOBILIZATION DEVICE MR-BY 160 is the device name listed in this FDA 510(k) record. The listed applicant is Mri Devices Corp.. It received FDA 510(k) clearance on 2000-06-20 under 510(k) number K001303. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST IMMOBILIZATION DEVICE MR-BY 160?

BREAST IMMOBILIZATION DEVICE MR-BY 160 is a medical device that received FDA 510(k) clearance on 2000-06-20. The listed applicant is Mri Devices Corp.. The 510(k) number is K001303.

When did BREAST IMMOBILIZATION DEVICE MR-BY 160 receive FDA 510(k) clearance?

BREAST IMMOBILIZATION DEVICE MR-BY 160 received FDA 510(k) clearance on 2000-06-20, under 510(k) number K001303.

Who is the listed applicant for BREAST IMMOBILIZATION DEVICE MR-BY 160?

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

What is the FDA product code for BREAST IMMOBILIZATION DEVICE MR-BY 160?

The FDA product code for BREAST IMMOBILIZATION DEVICE MR-BY 160 is MOS.

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Other records listing Mri Devices Corp. as applicant

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K041286DYNACAD V1.0K041481MODEL BBC-127 BIOPSY BREAST COILK040348MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COILK040349MODIFICATION TO HRW-127 WRIST ARRAY COILK040288QSC-127-INT SHOULDER ARRAY COIL SETK033447CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376

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Related Devices (Code: MOS)

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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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