ViziShot FLEX

Bronchoscope Accessory

SPIRATION, INC.

The following data is part of a premarket notification filed by Spiration, Inc. with the FDA for Vizishot Flex.

Pre-market Notification Details

• Device ID: K152922
• 510k Number: K152922
• Device Name: ViziShot FLEX
• Classification: Bronchoscope Accessory
• Applicant: SPIRATION, INC. 6675 185th Ave NE Redmond, WA 98052
• Contact: Cyndy J Adams
• Correspondent: Cyndy J Adams; SPIRATION, INC. 6675 185th Ave NE Redmond, WA 98052
• Product Code: KTI
• CFR Regulation Number: 874.4680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-02
• Decision Date: 2016-02-19
• Summary: summary