510(k) K890126
K890126 is an FDA 510(k) premarket notification submitted by D.R.G. for the device "KAMED STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on April 21, 1989. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. D.R.G. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1989
- Date Received
- January 12, 1989
- 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