The following data is part of a premarket notification filed by Microvision Incorporated with the FDA for Nomad Nd1000m Augmented Vision System.
Device ID | K030940 |
510k Number | K030940 |
Device Name: | NOMAD ND1000M AUGMENTED VISION SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | MICROVISION INCORPORATED 19910 NORTH CREEK PKWY. Bothell, WA 98011 |
Contact | Karl Bylund |
Correspondent | Charles Mack UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-03-25 |
Decision Date | 2003-04-09 |
Summary: | summary |