510(k) K081032
K081032 is an FDA 510(k) premarket notification submitted by Rnk Products, Inc. for the device "TR-USB TELEPHONIC STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on June 6, 2008. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Rnk Products, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2008
- Date Received
- April 11, 2008
- 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