NIGHT SHIFT

Pillow, Cervical (for Mild Sleep Apnea)

ADVANCED BRAIN MONITORING, INC.

The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for Night Shift.

Pre-market Notification Details

• Device ID: K140190
• 510k Number: K140190
• Device Name: NIGHT SHIFT
• Classification: Pillow, Cervical (for Mild Sleep Apnea)
• Applicant: ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD E Dousman, WI 53118
• Contact: Adrienne Lenz
• Correspondent: Adrienne Lenz; ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD E Dousman, WI 53118
• Product Code: MYB
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-24
• Decision Date: 2014-05-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851113007031	K140190	000
40850015266193	K140190	000
30850015266196	K140190	000
20850015266199	K140190	000
00850015266232	K140190	000
00850015266218	K140190	000
00850015266195	K140190	000
00850015266515	K140190	000
00850015266508	K140190	000
00850015266492	K140190	000
10850015266192	K140190	000
00850063034265	K140190	000
00850063034289	K140190	000
00850063034272	K140190	000
50850015266190	K140190	000
60850015266197	K140190	000
80850015266191	K140190	000
00851113007994	K140190	000
00850015266188	K140190	000
00850015266171	K140190	000
00850015266164	K140190	000
00850015266157	K140190	000
00850015266140	K140190	000
00850015266133	K140190	000
00850015266126	K140190	000
00850015266119	K140190	000
00850015266102	K140190	000
00850015266096	K140190	000
00850015266089	K140190	000
00850015266072	K140190	000
00850063034302	K140190	000