510(k) K822135

SECA DIGITAL BABY SCALE 727 by Seca Corp. — Product Code FRW

K822135 is an FDA 510(k) premarket notification submitted by Seca Corp. for the device "SECA DIGITAL BABY SCALE 727". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Seca Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
July 20, 1982
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