510(k) K840250

CARRIER by Convaid Products, Inc. — Product Code LBE

K840250 is an FDA 510(k) premarket notification submitted by Convaid Products, Inc. for the device "CARRIER". The FDA issued a decision of Substantially Equivalent on February 9, 1984. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850. Convaid Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1984
Date Received
January 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stroller, Adaptive
Device Class
Class I
Regulation Number
890.3850
Review Panel
PM
Submission Type