510(k) K894295
K894295 is an FDA 510(k) premarket notification submitted by Astro-Med, Inc. for the device "ASTRO-MED ASC-951 PRESSURE PROCESSOR". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Astro-Med, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1990
- Date Received
- June 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Transducer Signal
- Device Class
- Class II
- Regulation Number
- 870.2060
- Review Panel
- CV
- Submission Type