WS 800R Thermal Array Recorder
FDA 510(k) K881831 · Nihon Kohden America, Inc.
510(k) numberK881831
Submission
- Device name
- WS 800R Thermal Array Recorder
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- April 29, 1988
- Decision date
- July 14, 1988
- 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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| 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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Questions and answers
When was WS 800R Thermal Array Recorder cleared by the FDA?
WS 800R Thermal Array Recorder (K881831) received a 510(k) decision of Substantially Equivalent on July 14, 1988, 76 days after the submission was received.
What is the product code of K881831?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.