510(k) K821909
K821909 is an FDA 510(k) premarket notification submitted by 3M Company for the device "LITTMAN TUNABLE STETHOSCOPE 2136". The FDA issued a decision of Substantially Equivalent on July 14, 1982. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1982
- Date Received
- June 28, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Manual
- Device Class
- Class I
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type