Narco Air-Sheilds Sys. 100 Monitor Sys
FDA 510(k) K802800 · Narco Air-Shields
510(k) numberK802800
Submission
- Device name
- Narco Air-Sheilds Sys. 100 Monitor Sys
- Applicant
- Narco Air-Shields
Mchenry, IL, US - Received
- November 6, 1980
- Decision date
- November 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K820114 | System V.Heart Rate/Respir. Rate Monit.DRT · Traditional | 02/12/1982SE |
| K810953 | Model 533 Phototherapy UnitLBI · Traditional | 04/23/1981SE |
| K810474 | Probe CoverFLL · Traditional | 03/31/1981SE |
| K802126 | Isolette Incubator C-100FMZ · Traditional | 09/26/1980SE |
| K792592 | Ambu Universal Suction PumpJCX · Traditional | 01/11/1980SE |
| K792499 | Ambu Paedi Anaesthesia SystemCAI · Traditional | 12/19/1979SE |
| K792118 | Air-Shields ResuscitatorsBTM · Traditional | 11/13/1979SE |
| K792117 | Air-Shields Heart Rate MonitorDRT · Traditional | 11/13/1979SE |
| K790552 | AS7 & AS8 MonitorsDRT · Traditional | 05/01/1979SE |
| K790551 | Transport IncubatorFPL · Traditional | 04/24/1979SE |
Questions and answers
When was Narco Air-Sheilds Sys. 100 Monitor Sys cleared by the FDA?
Narco Air-Sheilds Sys. 100 Monitor Sys (K802800) received a 510(k) decision of Substantially Equivalent on November 24, 1980, 18 days after the submission was received.
What is the product code of K802800?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.