Oxygen Concentration Indicator
FDA 510(k) K944654 · Aequitron Medical, Inc.
510(k) numberK944654
Submission
- Device name
- Oxygen Concentration Indicator
- Applicant
- Aequitron Medical, Inc.
Plymouth, MN, US - Received
- September 21, 1994
- Decision date
- November 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
More from Envitec-Wismar GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K961972 | Model Ami Infant Central Aphea/Heart Rate MonitorBZQ · Traditional | 04/18/1997ST |
| K952880 | Model LP-1000 Volume VentilatorCBK · Traditional | 06/20/1996ST |
| K914424 | Model 6213 Remote AlarmCBK · Traditional | 09/10/1992SE |
| K915381 | Portable Oxygen GeneratorCAW · Traditional | 03/11/1992SE |
| K911399 | Nasal CPAP (Continuous Positive Air Pressure Syst)DZD · Traditional | 09/19/1991SE |
| K903020 | Respiration/Heart Rate Monitor Model 9500/9550BZQ · Traditional | 04/10/1991SE |
| K905244 | Model LP6 Ventilator, ModificationCBK · Traditional | 11/30/1990SE |
| K903010 | Continuous Volume Ventilator Model LP10CBK · Traditional | 11/30/1990SE |
| K902785 | Modified Models 9500,9550,9200,8200,HEART Rate MonBZQ · Traditional | 07/13/1990SE |
| K901656 | Model 9200 Respiration/Heart Rate MonitorBZQ · Traditional | 07/13/1990SE |
Questions and answers
When was Oxygen Concentration Indicator cleared by the FDA?
Oxygen Concentration Indicator (K944654) received a 510(k) decision of Substantially Equivalent on November 8, 1994, 48 days after the submission was received.
What is the product code of K944654?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.