510(k) K930118
K930118 is an FDA 510(k) premarket notification submitted by Nova Diversified Concepts for the device "STETSKINS". The FDA issued a decision of Substantially Equivalent on March 26, 1993. The device falls under product code BZS (Stethoscope Head), a Class I device regulated under 21 CFR 868.1930.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1993
- Date Received
- January 11, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope Head
- Device Class
- Class I
- Regulation Number
- 868.1930
- Review Panel
- AN
- Submission Type