510(k) K971570
K971570 is an FDA 510(k) premarket notification submitted by Quinton Electrophysiology Corp. for the device "EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391". The FDA issued a decision of Substantially Equivalent on December 29, 1997. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Quinton Electrophysiology Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1997
- Date Received
- April 29, 1997
- 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