CHECKPOINT

Stimulator, Nerve

NDI MEDICAL LLC

The following data is part of a premarket notification filed by Ndi Medical Llc with the FDA for Checkpoint.

Pre-market Notification Details

• Device ID: K092292
• 510k Number: K092292
• Device Name: CHECKPOINT
• Classification: Stimulator, Nerve
• Applicant: NDI MEDICAL LLC 22901 MILLCREEK BOULEVARD SUITE 110 Cleveland, OH 44122
• Contact: Julie Grill
• Correspondent: Julie Grill; NDI MEDICAL LLC 22901 MILLCREEK BOULEVARD SUITE 110 Cleveland, OH 44122
• Product Code: ETN
• CFR Regulation Number: 874.1820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-29
• Decision Date: 2009-10-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B13090941	K092292	000
B13090951	K092292	000
B13090921	K092292	000
B13095061	K092292	000
B13095051	K092292	000
B13095041	K092292	000