The following data is part of a premarket notification filed by Adaptive Healthcare Technologies, Inc. with the FDA for Navigator I.
| Device ID | K032879 |
| 510k Number | K032879 |
| Device Name: | NAVIGATOR I |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. P.O. BOX 614 Marstons Mills, MA 02648 |
| Contact | Joan Johnson |
| Correspondent | Joan Johnson ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. P.O. BOX 614 Marstons Mills, MA 02648 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2003-11-13 |
| Summary: | summary |