CipherOx CRI Tablet

Adjunctive Cardiovascular Status Indicator

Flashback Technologies, Inc.

The following data is part of a De Novo classification by Flashback Technologies, Inc. with the FDA for Cipherox Cri Tablet.

Pre-market Notification Details

• DeNovo ID: DEN160020
• Device Name: CipherOx CRI Tablet
• Classification: Adjunctive Cardiovascular Status Indicator
• Applicant: Flashback Technologies, Inc. 1215 Spruce Street, Suite 101 Boulder, CO 80302
• Contact: Gordon Van Dusen
• Product Code: PPW
• CFR Regulation Number: 870.2200 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Cardiovascular
• Classification Advisory: Cardiovascular
• Type: Direct
• Date Received: 2016-05-24
• Decision Date: 2016-12-21
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860003025604	DEN160020	000