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FDA 510(k)

BELLA

K-Number: K073262 · 2008-03-26

ApplicantBeekley Corp.
Decision Date2008-03-26
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BELLA is the device name listed in this FDA 510(k) record. The listed applicant is Beekley Corp.. It received FDA 510(k) clearance on 2008-03-26 under 510(k) number K073262. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLA?

BELLA is a medical device that received FDA 510(k) clearance on 2008-03-26. The listed applicant is Beekley Corp.. The 510(k) number is K073262.

When did BELLA receive FDA 510(k) clearance?

BELLA received FDA 510(k) clearance on 2008-03-26, under 510(k) number K073262.

Who is the listed applicant for BELLA?

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

What is the FDA product code for BELLA?

The FDA product code for BELLA is IZH.

Related Clinical Trials

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.

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Other records listing Beekley Corp. as applicant

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.

K020624BREAST BOLSTER

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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