510(k) K050097
K050097 is an FDA 510(k) premarket notification submitted by Techtrade, LLC for the device "TECHNO-SCOPE VISUAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on September 30, 2005. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Techtrade, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2005
- Date Received
- January 14, 2005
- 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