510(k) K902669

BPA, BODY POSITION ALARM by Bagrad — Product Code LZW

K902669 is an FDA 510(k) premarket notification submitted by Bagrad for the device "BPA, BODY POSITION ALARM". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code LZW (Monitor, Spine Curvature), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
June 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Spine Curvature
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type