BABY BOARD

Board, Arm (with Cover), Sterile

SENTRY MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Baby Board.

Pre-market Notification Details

• Device ID: K935098
• 510k Number: K935098
• Device Name: BABY BOARD
• Classification: Board, Arm (with Cover), Sterile
• Applicant: SENTRY MEDICAL PRODUCTS, INC. 17171 MURPHY AVE. Irvine, CA 92614 -5915
• Contact: John Nielsen
• Correspondent: John Nielsen; SENTRY MEDICAL PRODUCTS, INC. 17171 MURPHY AVE. Irvine, CA 92614 -5915
• Product Code: BTX
• CFR Regulation Number: 878.3910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-25
• Decision Date: 1994-02-15