Accu O2 Oxygen Analyzer
FDA 510(k) K173807 · Precision Medical, Inc.
510(k) numberK173807
Submission
- Device name
- Accu O2 Oxygen Analyzer
- Applicant
- Precision Medical, Inc.
Northampton, PA, US - Received
- December 15, 2017
- Decision date
- May 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | Maxtec, LLC | 12/14/2011SE |
More from Maxtec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K140179 | Easy Go VacBTA · Special | 04/25/2014SE |
| K103563 | Precision Portable Oxygen Concentration Model 4150CAW · Traditional | 07/01/2011SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | 04/21/2011SE |
| K090781 | HELIO2 BlenderBZR · Traditional | 08/13/2009SE |
| K072348 | Precision Oxygen ConcentratorCAW · Abbreviated | 10/27/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | 02/27/2007SE |
| K053232 | Precision BlenderBZR · Traditional | 01/10/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | 12/09/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | 10/04/2004SE |
| K032018 | Easy Pulse II Oxygen ConserverNFB · Traditional | 08/25/2003SE |
Questions and answers
When was Accu O2 Oxygen Analyzer cleared by the FDA?
Accu O2 Oxygen Analyzer (K173807) received a 510(k) decision of Substantially Equivalent on May 2, 2018, 138 days after the submission was received.
What is the product code of K173807?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.