510(k) K864953

WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE by Dittmar and Penn Corp. — Product Code FRW

K864953 is an FDA 510(k) premarket notification submitted by Dittmar and Penn Corp. for the device "WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE". The FDA issued a decision of Substantially Equivalent on January 21, 1987. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Dittmar and Penn Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1987
Date Received
December 18, 1986
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