Respiratory Gas Analyzer
FDA 510(k) K823449 · Thoratec Laboratories Corp.
510(k) numberK823449
Submission
- Device name
- Respiratory Gas Analyzer
- Applicant
- Thoratec Laboratories Corp.
Walker, MI, US - Received
- November 12, 1982
- Decision date
- January 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
Other 510(k)s with product code CCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K251245 | OxyMinder Pro (10310)CCL · Traditional | Bio-Med Device, Inc. | 08/11/2025SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional | GE Healthcare Finland Oy | 02/28/2013SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
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|---|---|---|
| K001927 | Vectra (TM) Vascular Access GRAFT-5MM DIAMETER,6MM Diameter and Vectra (TM) Vascular…DSY · Traditional | 12/18/2000SE |
| K001926 | Vascular Graft Tunneler-Standard Curve, Mid Curve, Full Curve, Short Standard Curve…DYB · Traditional | 09/22/2000SE |
| K851495 | Thoratec Multilumen Central Venous Cath-Tray · Traditional | 08/01/1985SESD |
| K833714 | Respiratory Assessment SystemBZL · Traditional | 12/29/1983SE |
| K833265 | Respiratory Flow ModuleJAX · Traditional | 11/28/1983SE |
| K831557 | Intraoperative Autotransfusion SysCAC · Traditional | 08/24/1983SE |
| K823287 | Respiratory Circuit AdaptorBZO · Traditional | 12/09/1982SE |
| K822769 | Thoratec Gas Sampling ConnectorCAI · Traditional | 10/06/1982SE |
| K780247 | Impco Disposable Aortic PunchDWS · Traditional | 02/27/1978SE |
Questions and answers
When was Respiratory Gas Analyzer cleared by the FDA?
Respiratory Gas Analyzer (K823449) received a 510(k) decision of Substantially Equivalent on January 5, 1983, 54 days after the submission was received.
What is the product code of K823449?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.