510(k) K981730

DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 by Nk Biotechnical Corp. — Product Code LBB

K981730 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Corp. for the device "DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002". The FDA issued a decision of Substantially Equivalent on July 17, 1998. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240. Nk Biotechnical Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
May 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type