The following data is part of a premarket notification filed by Fasstech with the FDA for Insight Discovery.
| Device ID | K063447 |
| 510k Number | K063447 |
| Device Name: | INSIGHT DISCOVERY |
| Classification | Electromyograph, Diagnostic |
| Applicant | FASSTECH 76 TREBLE COVE RD. BUILDING #2 North Billerica, MA 01862 |
| Contact | Lee Brody |
| Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890477000098 | K063447 | 000 |
| 00890477000296 | K063447 | 000 |
| 00890477000180 | K063447 | 000 |
| 00890477000173 | K063447 | 000 |
| 00890477000159 | K063447 | 000 |
| 00890477000104 | K063447 | 000 |
| 00890477000081 | K063447 | 000 |
| 00890477000074 | K063447 | 000 |
| 00890477000166 | K063447 | 000 |