Skip to content

Nellcor Stat-Cap Airway CO2 Indicator, Model N-60

by Nellcor, Inc.

510(k) K915494

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915494 Date6 Aug 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nellcor Stat-Cap Airway Co2 Indicator, Model N-60 is an analyzer, gas, carbon-dioxide, gaseous-phase device. It is used to indicate the level of carbon dioxide in the airway. The device is classified as a Class II device with special controls. The Nellcor Stat-Cap Airway Co2 Indicator, Model N-60 is a specific model of the device, with the product code CCK.

The device is supplied by Nellcor, Inc. and has received FDA 510(k) clearance, with the k number K915494. The device is intended for use in anesthesiology. The Nellcor Stat-Cap Airway Co2 Indicator, Model N-60 is a single device with a specific model number, and it is not specified if it is single-use or reusable. The storage and MRI safety information are not provided.

Other devices from Nellcor, Inc.

See all devices from Nellcor, Inc. →