510(k) K870600
K870600 is an FDA 510(k) premarket notification submitted by Kalajian Ent. for the device "SOFT EAR STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code CBG (Spreader, Cuff), a Class I device regulated under 21 CFR 868.5760. Kalajian Ent. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1987
- Date Received
- February 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spreader, Cuff
- Device Class
- Class I
- Regulation Number
- 868.5760
- Review Panel
- AN
- Submission Type