Sentorr Arterial Pressure Sensor
FDA 510(k) K880830 · Ohmeda Medical
510(k) numberK880830
Submission
- Device name
- Sentorr Arterial Pressure Sensor
- Applicant
- Ohmeda Medical
Tampa, FL, US - Received
- March 1, 1988
- Decision date
- August 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXO – Transducer, Pressure, Catheter Tip
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2870
- Specialty
- Cardiovascular
Other 510(k)s with product code DXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 02/12/2025SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | Acist Medical Systems, Inc. | 07/17/2024SE |
| K222216 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 12/22/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 06/18/2020SE |
| K193279 | Comet II Pressure GuidewireDXO · Special | Boston Scientific Corporation | 12/23/2019SE |
| K192340 | OptoMonitorDXO · Traditional | Opsens, Inc. | 12/12/2019SE |
| K190852 | Zurich Pressure Guidewire System Model 100DXO · Traditional | Zurich Medical, Inc. | 08/14/2019SE |
| K183413 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifeciences, LLC | 05/01/2019SE |
More from Edwards Lifeciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K123309 | Giraffe and Panda WarmersFMT · Traditional | 02/05/2013SE |
| K101788 | Giraffe OmnibedFMZ · Special | 07/21/2010SE |
| K101778 | Giraffe IncubatorFMZ · Special | 07/21/2010SE |
| K090697 | Modification to: Giraffe and Panda WarmerFMT · Special | 04/16/2009SE |
| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)FMT · Special | 08/27/2007SE |
| K070377 | Giraffe and Panda WarmerFMT · Traditional | 07/11/2007SE |
| K070247 | Giraffe and Panda Bag and Mask Resuscitation SystemBTM · Traditional | 04/20/2007SE |
| K070210 | Giraffe and Panda T- Piece Resuscitation SystemBTL · Traditional | 04/20/2007SE |
| K040068 | Biliblanket Plus High Output Phototherapy SystemFMZ · Traditional | 04/16/2004SE |
| K020547 | Ohmeda Medical Giraffe IncubatorFMZ · Traditional | 05/09/2002SE |
Questions and answers
When was Sentorr Arterial Pressure Sensor cleared by the FDA?
Sentorr Arterial Pressure Sensor (K880830) received a 510(k) decision of Substantially Equivalent on August 12, 1988, 164 days after the submission was received.
What is the product code of K880830?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.