Monitor, Oxychek Oxygen
FDA 510(k) K782114 · Critikon Company, LLC
510(k) numberK782114
Submission
- Device name
- Monitor, Oxychek Oxygen
- Applicant
- Critikon Company, LLC
Mchenry, IL, US - Received
- December 20, 1978
- Decision date
- January 18, 1979
- 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 |
More from Envitec-Wismar GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K002248 | Dinamap Pro 1000 Monitor, Model 1000DXN · Traditional | 09/21/2000SE |
| K000500 | Dinamap Advanced Nibp ModuleDXN · Traditional | 05/26/2000SE |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400MWI · Traditional | 02/24/2000SE |
| K982342 | Dinamap MPS Select Portable MonitorMSX · Traditional | 08/14/1998SE |
| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
| K942700 | Dinamap Vital Signs Monitor Models 9300 and 9320/9340MHX · Traditional | 03/01/1995SE |
| K933404 | Critikon Central Statin MonitorDPS · Traditional | 02/09/1994SE |
| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | 05/17/1993SE |
Questions and answers
When was Monitor, Oxychek Oxygen cleared by the FDA?
Monitor, Oxychek Oxygen (K782114) received a 510(k) decision of Substantially Equivalent on January 18, 1979, 29 days after the submission was received.
What is the product code of K782114?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.