Astro-Med, Inc.
Medical device manufacturer in West Warwick, RI.
13510(k) clearances
0PMA approvals
0recalls
Device types
- DRR Amplifier And Signal Conditioner… 2
- DSF Recorder, Paper Chart 2
- OLV Standard Polysomnograph With… 2
- DSH Recorder, Magnetic Tape, Medical 1
- DRQ Amplifier And Signal Conditioner… 1
- GWK Conditioner, Signal, Physiological 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- GWL Amplifier, Physiological Signal 1
- GWQ Full-Montage Standard Electroencephalograph 1
- OMA Amplitude-Integrated Electroencephalograph 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K081551 | Twin Neurotrac-IiiOMA · Traditional | 12/24/2008SE |
| K050425 | Aura-PsgOLV · Traditional | 10/20/2005SE |
| K033978 | AdamGWQ · Traditional | 02/18/2004SE |
| K970951 | Grass Brainwave SoftwareOLV · Traditional | 05/19/1997SE |
| K963669 | Grass Model 15 Neurodata Amplifier SystemGWL · Traditional | 12/12/1996SE |
| K934644 | K3 SystemDRT · Traditional | 11/01/1994SE |
| K912929 | Dash IVDSF · Traditional | 08/13/1991SE |
| K896164 | ASC-954 Integrator AmplifierGWK · Traditional | 01/22/1990SE |
| K894295 | Astro-Med ASC-951 Pressure ProcessorDRQ · Traditional | 01/18/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | 12/13/1989SE |
| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | 09/18/1989SE |
| K894161 | ASC-950 ECG AmplifierDRR · Traditional | 08/03/1989SE |
| K892067 | MT9000 Chart RecorderDSH · Traditional | 06/05/1989SE |