510(k) K894735
K894735 is an FDA 510(k) premarket notification submitted by Astro-Med, Inc. for the device "ASC-952 PHYSIOLOGICAL AMPLIFIER". The FDA issued a decision of Substantially Equivalent on September 18, 1989. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Astro-Med, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1989
- Date Received
- July 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Biopotential
- Device Class
- Class II
- Regulation Number
- 870.2050
- Review Panel
- CV
- Submission Type