PAQ10 Paper Chart Recorder
FDA 510(k) K894607 · Protocol Systems, Inc.
510(k) numberK894607
Submission
- Device name
- PAQ10 Paper Chart Recorder
- Applicant
- Protocol Systems, Inc.
Beaverton, OR, US - Received
- July 20, 1989
- Decision date
- October 26, 1989
- 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
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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 |
| K893561 | Edentrace 670 System Multichannel Recorder W/Oxim.DSF · Traditional | Edentec Corp. | 08/25/1989SE |
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| K945071 | Propaq 200 MonitorDRT · Traditional | 05/10/1995SE |
| K935846 | Model Acuity Central StationDSI · Traditional | 12/05/1994SE |
| K934711 | Propaq ECG Telemetry OptionDRG · Traditional | 09/01/1994SE |
| K921497 | Propaq Monitors, ModificationCCK · Traditional | 03/23/1993SE |
| K914838 | Propaq 102,104,106,102EL,104EL,&106ELMHX · Traditional | 01/10/1992SE |
| K913193 | Model 100 Central StationDQK · Traditional | 10/16/1991SE |
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Questions and answers
When was PAQ10 Paper Chart Recorder cleared by the FDA?
PAQ10 Paper Chart Recorder (K894607) received a 510(k) decision of Substantially Equivalent on October 26, 1989, 98 days after the submission was received.
What is the product code of K894607?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.