Colorado Color Imaging Recorder
FDA 510(k) K902230 · Honeywell, Inc.
510(k) numberK902230
Submission
- Device name
- Colorado Color Imaging Recorder
- Applicant
- Honeywell, Inc.
Denver, CO, US - Received
- May 17, 1990
- Decision date
- June 19, 1990
- 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 |
| 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 |
| K893561 | Edentrace 670 System Multichannel Recorder W/Oxim.DSF · Traditional | Edentec Corp. | 08/25/1989SE |
More from Edentec Corp.
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| K855125 | Physiological Telemetry Patient Monitoring SystemDRT · Traditional | 03/26/1986SE |
| K851888 | Apm Dispos. Blood Pressure TransducerDRS · Traditional | 08/06/1985SE |
| K851496 | ECG Monitor Model RM102DXJ · Traditional | 07/24/1985SE |
| K850794 | Patient Monitor Model RM-300DTR · Traditional | 04/18/1985SE |
| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
| K834282 | Ultra Imager 2000IYO · Traditional | 04/23/1984SE |
| K840167 | Portable DefibrillatorLDD · Traditional | 02/04/1984SE |
Questions and answers
When was Colorado Color Imaging Recorder cleared by the FDA?
Colorado Color Imaging Recorder (K902230) received a 510(k) decision of Substantially Equivalent on June 19, 1990, 33 days after the submission was received.
What is the product code of K902230?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.