Company ยท US
Astro-Med, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2008. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | 2 |
| DSF | Recorder, Paper Chart | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| GWK | Conditioner, Signal, Physiological | 1 |
| GWL | Amplifier, Physiological Signal | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 24, 2008 | K081551 | TWIN NEUROTRAC-III Astro-Med, Inc. | OMA |
| Oct 20, 2005 | K050425 | AURA-PSG Astro-Med, Inc. | OLV |
| Feb 18, 2004 | K033978 | ADAM Astro-Med, Inc. | GWQ |
| May 19, 1997 | K970951 | GRASS BRAINWAVE SOFTWARE Astro-Med, Inc. | OLV |
| Dec 12, 1996 | K963669 | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM Astro-Med, Inc. | GWL |
| Nov 1, 1994 | K934644 | K3 SYSTEM Astro-Med, Inc. | DRT |
| Aug 13, 1991 | K912929 | DASH IV Astro-Med, Inc. | DSF |
| Jan 22, 1990 | K896164 | ASC-954 INTEGRATOR AMPLIFIER Astro-Med, Inc. | GWK |
| Jan 18, 1990 | K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR Astro-Med, Inc. | DRQ |
| Dec 13, 1989 | K894736 | MT96000 PAPER CHART RECORDER Astro-Med, Inc. | DSF |
| Sep 18, 1989 | K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER Astro-Med, Inc. | DRR |
| Aug 3, 1989 | K894161 | ASC-950 ECG AMPLIFIER Astro-Med, Inc. | DRR |
| Jun 5, 1989 | K892067 | MT9000 CHART RECORDER Astro-Med, Inc. | DSH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||