Recorder, RE-100P Hot Stylus Strip Chart
FDA 510(k) K780245 · Waters Assoc., Inc.
510(k) numberK780245
Submission
- Device name
- Recorder, RE-100P Hot Stylus Strip Chart
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- February 13, 1978
- Decision date
- March 27, 1978
- 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 |
More from Protocol Systems, Inc.
| 510(k) | Device | Decision |
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| K811975 | Model 480 Variable Wavelength Ultra ViolJJQ · Traditional | 07/27/1981SE |
| K802481 | 7FRENCH Flow Directed Triple Lumen CathDYG · Traditional | 10/31/1980SE |
| K801852 | MRM-2 Oxygen Consumption MonitorBZL · Traditional | 08/20/1980SE |
| K801431 | Pan-Am Myelogram TrayFMI · Traditional | 08/12/1980SE |
| K791661 | System Controller 720 SeriesKIE · Traditional | 09/24/1979SE |
| K791026 | 4F Sterile Balloon-Less, Catheter 913-28KRB · Traditional | 06/22/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | 02/15/1979SE |
| K782175 | Cartridge Holder, RCM 100KIE · Traditional | 02/15/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | 01/29/1979SE |
| K781915 | Data ModuleKIE · Traditional | 01/10/1979SE |
Questions and answers
When was Recorder, RE-100P Hot Stylus Strip Chart cleared by the FDA?
Recorder, RE-100P Hot Stylus Strip Chart (K780245) received a 510(k) decision of Substantially Equivalent on March 27, 1978, 42 days after the submission was received.
What is the product code of K780245?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.