BELLA— 510(k) K073262

Substantially Equivalent

Beekley Corp.

FDA 510(k) clearance K073262 for BELLA, Substantially Equivalent on 2008-03-26. Applicant: Beekley Corp.. Device class: 2.

Clearance details

Applicant: Beekley Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2007-11-20
Decision date: 2008-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Beekley Corp.

K020624 — BREAST BOLSTER2002-09-12

Recalls naming K073262

K-number listed on FDA's recall record

Z-2080-2012 — Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.Class II·Terminated·Beekley Corporation·20120702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073262.

Data sourced from openFDA. This site is unofficial and independent of the FDA.