The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Insight, Model S980000.
| Device ID | K012232 |
| 510k Number | K012232 |
| Device Name: | INSIGHT, MODEL S980000 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | SANDHILL SCIENTIFIC, INC. 4655 KIRKWOOD CT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward SANDHILL SCIENTIFIC, INC. 4655 KIRKWOOD CT Boulder, CO 80301 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2002-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B019D8231030 | K012232 | 000 |
| 00816734023457 | K012232 | 000 |
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