510(k) K771580
K771580 is an FDA 510(k) premarket notification submitted by Scientific Products for the device "TEKTALLY II". The FDA issued a decision of Substantially Equivalent on September 2, 1977. The device falls under product code GKM (Hand-Tally, Differential), a Class I device regulated under 21 CFR 864.6160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1977
- Date Received
- August 18, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hand-Tally, Differential
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type