510(k) K102893
K102893 is an FDA 510(k) premarket notification submitted by Rnk Products, Inc. for the device "PCP/PC STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on January 20, 2011. 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
- January 20, 2011
- Date Received
- September 30, 2010
- 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