Model 16800 Trend Recorder
FDA 510(k) K821612 · Healthdyne, Inc.
510(k) numberK821612
Submission
- Device name
- Model 16800 Trend Recorder
- Applicant
- Healthdyne, Inc.
Mchenry, IL, US - Received
- June 2, 1982
- Decision date
- July 14, 1982
- 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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| K942357 | H-500 Alliance Oxygen ConcentratorCAW · Traditional | 05/27/1994SE |
| K934502 | Flow SpirometerBZH · Traditional | 04/04/1994SE |
| K924146 | OH-500 Oxygen ConcentratorCAW · Traditional | 01/07/1993SE |
| K922623 | Nebulizer SystemBTI · Traditional | 12/01/1992SE |
| K910118 | Data RecorderFLL · Traditional | 02/14/1991SE |
| K903287 | Model 900S Apnea/Heart MonitorBZQ · Traditional | 08/17/1990SE |
| K894030 | Model 37 Uterine Contraction Activity MonitorHFM · Traditional | 01/22/1990SE |
| K892006 | Healthdyne's Apnea/Heart Monitor, Model 900SDRT · Traditional | 05/23/1989SE |
Questions and answers
When was Model 16800 Trend Recorder cleared by the FDA?
Model 16800 Trend Recorder (K821612) received a 510(k) decision of Substantially Equivalent on July 14, 1982, 42 days after the submission was received.
What is the product code of K821612?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.