Model 192 Printer
FDA 510(k) K870538 · Advanced Medical Products, Inc.
510(k) numberK870538
Submission
- Device name
- Model 192 Printer
- Applicant
- Advanced Medical Products, Inc.
E. Syracuse, NY, US - Received
- February 9, 1987
- Decision date
- April 23, 1987
- 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 |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
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| K921426 | Ultra PciIYO · Traditional | 10/05/1992SE |
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| K915658 | Spectra ECGLOS · Traditional | 06/10/1992SE |
| K896103 | Micro FL 7400 Ambulatory Holter/Bp MonitorDSI · Traditional | 01/18/1990SE |
| K896102 | Micro FD 7000 Ambulatory Blood Pressure MonitorDXN · Traditional | 01/18/1990SE |
| K881905 | Model Micro Si Ambulatory ECG MonitorDSI · Traditional | 08/02/1988SE |
| K872508 | Model Micro Fd+ Ambulatory ECG MonitorDSH · Traditional | 09/25/1987SE |
| K870537 | Model Micro ST Ambulatory ECG MonitorDSH · Traditional | 04/23/1987SE |
Questions and answers
When was Model 192 Printer cleared by the FDA?
Model 192 Printer (K870538) received a 510(k) decision of Substantially Equivalent on April 23, 1987, 73 days after the submission was received.
What is the product code of K870538?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.