510(k) K801050
K801050 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "SUPRA SCOPE". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code BZS (Stethoscope Head), a Class I device regulated under 21 CFR 868.1930. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1980
- Date Received
- May 5, 1980
- 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