FDA.reportPublic FDA data

CAPNIA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086149983008614998CAPNIA, INC.1N2026-01-011101 Chess Drive Foster City CA US 94404

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858481006017CoSense ETCO Monitor - A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.6502138444bhyatt@capnia.com
00858481006017CoSense ETCO Monitor - A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.8664323788ed.baumann@Capnia.com
00858481006024CO Sensor Module - This is the interchangeable Sensor Module which is inserted into the ETCO Monitor, the CO Sensor Module is replaceable. It has an expiration date. Note: The monitor is a reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.8664323788ed.baumann@Capnia.com
00858481006055CoSense Precision Sampling Set - The Precision Sampling Set is a single use microfluidic sampling set (nasal cannula). To ensure a valid sampling set is used, when the Precision Sampling Set is connected to the Monitor, there is an electronic handshake between it and the CoSense Monitor. Note: The CoSense Monitor is a reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.8664323788ed.baumann@Capnia.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2361051031174499K151107CoSense ETCO MonitorCCJ2015-07-22
2361051500117867K130036COSENSE CO MONITORCCJ2014-01-14
2361051258245247K121768COSENSECCJ2012-10-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CCJ32015-07-22

PMN#

GUDID#

CoSense Precision Sampling Set - The Precision Sampling Set is a single use microfluidic sampling set (nasal cannula). To ensure a valid sampling set is used, when the Precision Sampling Set is connected to the Monitor, there is an electronic handshake between it and the CoSense Monitor. Note: The CoSense Monitor is a reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.

Capnia, INC.

2026-05-06