SCOUT

Wheelchair, Powered

BURKE, INC.

The following data is part of a premarket notification filed by Burke, Inc. with the FDA for Scout.

Pre-market Notification Details

• Device ID: K982158
• 510k Number: K982158
• Device Name: SCOUT
• Classification: Wheelchair, Powered
• Applicant: BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106
• Contact: Duwayne E Kramer
• Correspondent: Duwayne E Kramer; BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-06-19
• Decision Date: 1998-08-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B314831811	K982158	000
B314811221	K982158	000
B31481445A1	K982158	000
B31481855A1	K982158	000
B314823381	K982158	000
B314824911	K982158	000
B314825541	K982158	000
B314825651	K982158	000
B314831731	K982158	000
B314831801	K982158	000
B31481113A1	K982158	000