Neocare Oxygen Monitor
FDA 510(k) K810571 · Vickers America Medical Corp.
510(k) numberK810571
Submission
- Device name
- Neocare Oxygen Monitor
- Applicant
- Vickers America Medical Corp.
Mchenry, IL, US - Received
- March 3, 1981
- Decision date
- March 11, 1981
- 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 |
|---|---|---|
| K840823 | Treonic C30LDR · Traditional | 03/23/1984SE |
| K831838 | Laboratory Data MGMT System SDMSJQP · Traditional | 01/24/1984SE |
| K830748 | ResuscitaireFMT · Traditional | 06/22/1983SE |
| K830936 | Treonic IP5FRN · Traditional | 04/12/1983SE |
| K813239 | Oxygenaire Nuring IncubatorFMZ · Traditional | 01/28/1982SE |
| K813238 | Neocare Baby-Controlled IncubatorFMZ · Traditional | 01/22/1982SE |
| K811865 | Vma Pediatric Apnea MattressBZQ · Traditional | 07/31/1981SE |
| K810792 | Neocare Temperature MonitorFMZ · Traditional | 04/29/1981SE |
| K810067 | 140 Neocare Air Controlled IncubatorFMZ · Traditional | 03/11/1981SE |
| K802251 | SP 120 SophisticateJQP · Traditional | 10/23/1980SE |
Questions and answers
When was Neocare Oxygen Monitor cleared by the FDA?
Neocare Oxygen Monitor (K810571) received a 510(k) decision of Substantially Equivalent on March 11, 1981, 8 days after the submission was received.
What is the product code of K810571?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.