Gabriel Medical CLS Thermal Recorder
FDA 510(k) K901385 · Gabriel Medical, Inc.
510(k) numberK901385
Submission
- Device name
- Gabriel Medical CLS Thermal Recorder
- Applicant
- Gabriel Medical, Inc.
Irvine, CA, US - Received
- March 26, 1990
- Decision date
- May 9, 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
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 |
| 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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| K960173 | Infra Vision Bougie Kit, Infra Vision Esophageal KitFAT · Traditional | 06/27/1996SE |
| K945088 | Gabriel Ureteral Illuminator System IIFCS · Traditional | 02/07/1995SE |
| K945297 | Infra Vision Imaging SystemGCJ · Traditional | 12/20/1994SE |
| K940019 | Gabriel Ureteral Illuminator SystemFCS · Traditional | 05/02/1994SE |
Questions and answers
When was Gabriel Medical CLS Thermal Recorder cleared by the FDA?
Gabriel Medical CLS Thermal Recorder (K901385) received a 510(k) decision of Substantially Equivalent on May 9, 1990, 44 days after the submission was received.
What is the product code of K901385?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.