510(k) K862885

CAR SEAT by Mednet, Inc. — Product Code INN

K862885 is an FDA 510(k) premarket notification submitted by Mednet, Inc. for the device "CAR SEAT". The FDA issued a decision of Substantially Equivalent on August 14, 1986. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100. Mednet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1986
Date Received
July 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Adjustable, Mechanical
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type