FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRO-MED ASC-951 PRESSURE PROCESSOR
K Number: K894295
·
Decision Jan 18, 1990
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
13
Review Days
209
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Basic Information
- Device Name
- ASTRO-MED ASC-951 PRESSURE PROCESSOR
- K Number
- K894295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2060
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Astro-Med, Inc.
- Date Received
- June 23, 1989
- Decision Date
- January 18, 1990
- Product Code
- DRQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | FDA class 2 | Cardiovascular |
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Other Clearances by Astro-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081551 | TWIN NEUROTRAC-III | Dec 24, 2008 | Substantially Equivalent |
| K050425 | AURA-PSG | Oct 20, 2005 | Substantially Equivalent |
| K033978 | ADAM | Feb 18, 2004 | Substantially Equivalent |
| K970951 | GRASS BRAINWAVE SOFTWARE | May 19, 1997 | Substantially Equivalent |
| K963669 | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM | Dec 12, 1996 | Substantially Equivalent |
| K934644 | K3 SYSTEM | Nov 1, 1994 | Substantially Equivalent |
| K912929 | DASH IV | Aug 13, 1991 | Substantially Equivalent |
| K896164 | ASC-954 INTEGRATOR AMPLIFIER | Jan 22, 1990 | Substantially Equivalent |
| K894736 | MT96000 PAPER CHART RECORDER | Dec 13, 1989 | Substantially Equivalent |
| K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER | Sep 18, 1989 | Substantially Equivalent |