Fukuda Denshi Model AU-5001-5003 Thermal
FDA 510(k) K852487 · Fukuda Denshi USA, Inc.
510(k) numberK852487
Submission
- Device name
- Fukuda Denshi Model AU-5001-5003 Thermal
- Applicant
- Fukuda Denshi USA, Inc.
Kirkland, WA, US - Received
- June 11, 1985
- Decision date
- September 19, 1985
- 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
Other 510(k)s with product code DSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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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| K112521 | Fukuda Denshi Vasera Model VS-1500DXN · Traditional | 12/21/2011SE |
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| K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…MHX · Traditional | 03/19/2009SE |
| K082656 | Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitIYN · Traditional | 09/30/2008SE |
| K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorMHX · Traditional | 08/29/2008SE |
| K050363 | Fukuda Denshi Model UF-850XTDIYN · Special | 02/17/2005SE |
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Questions and answers
When was Fukuda Denshi Model AU-5001-5003 Thermal cleared by the FDA?
Fukuda Denshi Model AU-5001-5003 Thermal (K852487) received a 510(k) decision of Substantially Equivalent on September 19, 1985, 100 days after the submission was received.
What is the product code of K852487?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.