Datalogger Chart Recorder
FDA 510(k) K880781 · Air-Shields, Inc.
510(k) numberK880781
Submission
- Device name
- Datalogger Chart Recorder
- Applicant
- Air-Shields, Inc.
Hatboro, PA, US - Received
- February 26, 1988
- Decision date
- May 11, 1988
- 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 |
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| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
Questions and answers
When was Datalogger Chart Recorder cleared by the FDA?
Datalogger Chart Recorder (K880781) received a 510(k) decision of Substantially Equivalent on May 11, 1988, 75 days after the submission was received.
What is the product code of K880781?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.