510(k) K782050

PRINTER, TEK PRO TEK TALLY II by Tekpro — Product Code GKZ

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