Long Term Recorder Rag 1200
FDA 510(k) K854866 · Nihon Kohden America, Inc.
510(k) numberK854866
Submission
- Device name
- Long Term Recorder Rag 1200
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- November 8, 1985
- Decision date
- April 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSF – Recorder, Paper Chart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2810
- Specialty
- Cardiovascular
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| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | Edentec Corp. | 08/29/1991SE |
| K912929 | Dash IVDSF · Traditional | Astro-Med, Inc. | 08/13/1991SE |
| K905856 | Model 556 MonitorDSF · Traditional | Ge Medical Systems Information Technologies | 01/11/1991SE |
| K902586 | Gri Lasergraph(Tm) ECG PaperDSF · Traditional | Gri Medical Products, Inc. | 06/22/1990SE |
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | Honeywell, Inc. | 06/19/1990SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
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| K082785 | Nihon Kohden Bedside Monitor, BSM 9100A SeriesMHX · Special | 11/26/2008SE |
| K071969 | SEN-4100 Electric StimulatorGWF · Traditional | 10/06/2008SE |
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| K073550 | Prefense EDNS-9000 Series Nurse Central StationMHX · Special | 03/28/2008SE |
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Questions and answers
When was Long Term Recorder Rag 1200 cleared by the FDA?
Long Term Recorder Rag 1200 (K854866) received a 510(k) decision of Substantially Equivalent on April 9, 1986, 152 days after the submission was received.
What is the product code of K854866?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.