Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
FDA 510(k) K082655 · Envitec-Wismar GmbH
510(k) numberK082655
Submission
- Device name
- Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
- Applicant
- Envitec-Wismar GmbH
Egale, WI, US - Received
- September 12, 2008
- Decision date
- November 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 510(k) | Device | Decision |
|---|---|---|
| K133064 | Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…DQA · Traditional | 05/02/2014SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | 01/23/2013SE |
| K102270 | Envitec Reusable SPO2 Sensors Type Nihon-KohdenDQA · Traditional | 02/22/2011SE |
| K090438 | Reusable Envitec Finger SPO2 Sensor-Hp/Philips Compatible, Models F-2412, F-2414-15…DQA · Traditional | 07/24/2009SE |
| K070193 | Envitec Oxipen Pulse Oximeter and AccessoriesDQA · Traditional | 05/02/2007SE |
| K060675 | Envitec Reusable Softip Y SPO2 SensorsDQA · Special | 07/17/2006SE |
| K043463 | Envitec Reusable Multi-Site Y SPO2 SensorsDQA · Traditional | 02/11/2005SE |
| K992215 | Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable…DQA · Traditional | 03/29/2000SE |
Questions and answers
When was Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 cleared by the FDA?
Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (K082655) received a 510(k) decision of Substantially Equivalent on November 25, 2008, 74 days after the submission was received.
What is the product code of K082655?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.