COSENSE

Analyzer, Gas, Carbon-monoxide, Gaseous-phase

Capnia, Inc.

The following data is part of a premarket notification filed by Capnia, Inc. with the FDA for Cosense.

Pre-market Notification Details

• Device ID: K121768
• 510k Number: K121768
• Device Name: COSENSE
• Classification: Analyzer, Gas, Carbon-monoxide, Gaseous-phase
• Applicant: Capnia, Inc. 2445 FABER PLACE, STUITE 250 Palo Alto, CA 94303
• Contact: Julie Blacklock
• Correspondent: Julie Blacklock; Capnia, Inc. 2445 FABER PLACE, STUITE 250 Palo Alto, CA 94303
• Product Code: CCJ
• CFR Regulation Number: 868.1430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-15
• Decision Date: 2012-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858481006017	K121768	000