Q-Cath RM
FDA 510(k) K883031 · Quinton, Inc.
510(k) numberK883031
Submission
- Device name
- Q-Cath RM
- Applicant
- Quinton, Inc.
Seattle, WA, US - Received
- July 19, 1988
- Decision date
- September 20, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K032038 | Pyramis ECG Management System Model Numbers, 92600 and 92601DQK · Abbreviated | 09/05/2003SE |
| K021906 | Quinton Q-Cath, Model 000460DQK · Abbreviated | 09/04/2002SE |
| K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated | 01/25/2001SE |
| K001492 | Quinton Q-Stress, Model 000483DPS · Abbreviated | 08/09/2000SE |
| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | 03/06/2000SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
| K964978 | Vital Statistics System (O-Cath Accessory)DQA · Traditional | 05/21/1997SE |
| K955002 | Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional | 09/13/1996SE |
Questions and answers
When was Q-Cath RM cleared by the FDA?
Q-Cath RM (K883031) received a 510(k) decision of Substantially Equivalent on September 20, 1988, 63 days after the submission was received.
What is the product code of K883031?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.