Issued: 4/4/11
Region: Central
Category: Device 483s
Inspection date range: 3/25/11-4/4/11
Pages: 3
Company: Neurowave Systems, Inc.
2490 Lee Blvd.
Ste. 300
Cleveland Hts., OH 44118-1268
Inspector(s): Laureen M. Geniusz
Observations: Procedures for design validation have not been adequately established.