Spacelabs' System Autorecorder
FDA 510(k) K811540 · Spacelabs, Inc.
510(k) numberK811540
Submission
- Device name
- Spacelabs' System Autorecorder
- Applicant
- Spacelabs, Inc.
Walker, MI, US - Received
- June 1, 1981
- Decision date
- August 13, 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 |
|---|---|---|
| K954962 | Spacelabs Medical Multigas AnalyzerCBR · Traditional | 05/31/1996SE |
| K951605 | Spacelabs Medical Casemaster Information Management SystemDSH · Traditional | 07/14/1995SE |
| K950779 | Heart Rate Variability Software OptionDPS · Traditional | 04/25/1995SE |
| K941165 | Comet Capnograph ModuleCCK · Traditional | 10/06/1994SE |
| K923788 | Space Labs Model 90560LOS · Traditional | 12/06/1993SE |
| K912742 | Esophageal Stethoscope Temperature ProbeFLL · Traditional | 04/20/1992SE |
| K913038 | Spacelab Model 90845 PCMS Multidisclosure StationDSH · Traditional | 10/04/1991SE |
| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
Questions and answers
When was Spacelabs' System Autorecorder cleared by the FDA?
Spacelabs' System Autorecorder (K811540) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 73 days after the submission was received.
What is the product code of K811540?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.