510(k) K782050
K782050 is an FDA 510(k) premarket notification submitted by Tekpro for the device "PRINTER, TEK PRO TEK TALLY II". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Tekpro has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1979
- Date Received
- December 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type