The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Manual Disposable Microdrive With Digital Display, Models Mi-1000 & Mi-1010.
| Device ID | K022100 |
| 510k Number | K022100 |
| Device Name: | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Contact | David M Lee |
| Correspondent | David M Lee IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-28 |
| Decision Date | 2002-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994747860 | K022100 | 000 |
| 00613994747853 | K022100 | 000 |
| 00643169986770 | K022100 | 000 |
| 00643169986763 | K022100 | 000 |
| 00873263007723 | K022100 | 000 |
| 00873263007716 | K022100 | 000 |