Central Station Controller AC100/CE100
FDA 510(k) K810169 · Honeywell, Inc.
510(k) numberK810169
Submission
- Device name
- Central Station Controller AC100/CE100
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- January 22, 1981
- Decision date
- February 25, 1981
- 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 |
|---|---|---|
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | 06/19/1990SE |
| K863100 | Cen Sta Mon Ac/Dc Alarm Central Acces Alarm RecorDPS · Traditional | 02/03/1987SE |
| K853501 | Honeywell Electronic Ventilator Ev-ACBK · Traditional | 04/04/1986SE |
| 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 |
Questions and answers
When was Central Station Controller AC100/CE100 cleared by the FDA?
Central Station Controller AC100/CE100 (K810169) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 34 days after the submission was received.
What is the product code of K810169?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.