510(k) K953833
K953833 is an FDA 510(k) premarket notification submitted by Flowscan, Inc. for the device "LIFE SOUND SENSOR AMPLIFIER-LISA". The FDA issued a decision of Substantially Equivalent on December 5, 1995. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Flowscan, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1995
- Date Received
- August 15, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type