Servomed Medivision Scope SMV-235
FDA 510(k) K840209 · Litton Medical Electronics
510(k) numberK840209
Submission
- Device name
- Servomed Medivision Scope SMV-235
- Applicant
- Litton Medical Electronics
Mchenry, IL, US - Received
- January 19, 1984
- Decision date
- September 20, 1984
- 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
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K840522 | Recomed Blood-Flow Meter H236-052-02DPW · Traditional | 05/16/1985SE |
| K840899 | Servomed Arrhycomp Central Monitor SysDSI · Traditional | 11/20/1984SE |
| K840439 | Recomed Cardiac Output Meter 236067-DXG · Traditional | 11/20/1984SE |
| K840523 | Servomed Pulse Amplifier MODULE-206-DRT · Traditional | 10/29/1984SE |
| K840524 | Servomed Basic Bedside Unit SMV 110TPDRT · Traditional | 10/26/1984SE |
| K840832 | Servomed Oxcardiore Spirograph 324/111DRT · Traditional | 09/20/1984SE |
| K840525 | Servomed Compact Monitor SMK 155-1/101DRT · Traditional | 06/01/1984SE |
| K840521 | Servomed Digital Display ModuleDRT · Traditional | 06/01/1984SE |
| K834600 | Recomb ECG PREAMPLIFIER/206 069 03DRT · Traditional | 06/01/1984SE |
| K833000 | I-Channel RecorderDSF · Traditional | 06/01/1984SE |
Questions and answers
When was Servomed Medivision Scope SMV-235 cleared by the FDA?
Servomed Medivision Scope SMV-235 (K840209) received a 510(k) decision of Substantially Equivalent on September 20, 1984, 245 days after the submission was received.
What is the product code of K840209?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.