510(k) K873917

TONOMETER TAPES by Richmond Products, Inc. — Product Code HKX

K873917 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "TONOMETER TAPES". The FDA issued a decision of Substantially Equivalent on November 2, 1987. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1987
Date Received
September 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type