510(k) K930626

SANITAS PATIENT SCALE by Dutton-Lainson Co. — Product Code FRW

K930626 is an FDA 510(k) premarket notification submitted by Dutton-Lainson Co. for the device "SANITAS PATIENT SCALE". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Dutton-Lainson Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
February 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Patient
Device Class
Class I
Regulation Number
880.2720
Review Panel
HO
Submission Type