BELLA

System, X-ray, Mammographic

BEEKLEY CORP.

The following data is part of a premarket notification filed by Beekley Corp. with the FDA for Bella.

Pre-market Notification Details

• Device ID: K073262
• 510k Number: K073262
• Device Name: BELLA
• Classification: System, X-ray, Mammographic
• Applicant: BEEKLEY CORP. 150 DOLPHIN RD. Bristol, CT 06011
• Contact: Martine M Boutte
• Correspondent: Martine M Boutte; BEEKLEY CORP. 150 DOLPHIN RD. Bristol, CT 06011
• Product Code: IZH
• CFR Regulation Number: 892.1710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-20
• Decision Date: 2008-03-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815137021251	K073262	000
00815137021244	K073262	000
00815137020247	K073262	000
00815137020230	K073262	000