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 |
|---|---|---|
| 00816734022726 | K012232 | 000 |
| B019PHI150 | K012232 | 000 |
| B019PHI50 | K012232 | 000 |
| B019PHIS0 | K012232 | 000 |
| B019PHN100 | K012232 | 000 |
| B019PHN10P0 | K012232 | 000 |
| B019PHN150 | K012232 | 000 |
| B019PHN210 | K012232 | 000 |
| B019PHN50 | K012232 | 000 |
| B019PHNS0 | K012232 | 000 |
| B019PHNSP0 | K012232 | 000 |
| B019S9819255P10 | K012232 | 000 |
| B019S9819256P10 | K012232 | 000 |
| B019S9819257P10 | K012232 | 000 |
| B019ULT1CIED0 | K012232 | 000 |
| B019ULT1HAD0 | K012232 | 000 |
| B019PHI100 | K012232 | 000 |
| B019H12R4500300 | K012232 | 000 |
| B019H12R45000 | K012232 | 000 |
| 00816734022146 | K012232 | 000 |
| 00816734022153 | K012232 | 000 |
| 00816734022184 | K012232 | 000 |
| B019A042000S0 | K012232 | 000 |
| B019A04R25000 | K012232 | 000 |
| B019CART5R0 | K012232 | 000 |
| B019D8231030 | K012232 | 000 |
| B019D8231510 | K012232 | 000 |
| B019D8231520 | K012232 | 000 |
| B019D8231810 | K012232 | 000 |
| B019D8231820 | K012232 | 000 |
| B019D8231830 | K012232 | 000 |
| B019EFTV12V0 | K012232 | 000 |
| B019H12R20000 | K012232 | 000 |
| B019H12R43000 | K012232 | 000 |
| B019ULT1HAI0 | K012232 | 000 |
| B019ULT1HCAD0 | K012232 | 000 |
| B019ULT1HD0 | K012232 | 000 |
| B019ZANBD310 | K012232 | 000 |
| B019ZANBG440 | K012232 | 000 |
| B019ZANBG44E0 | K012232 | 000 |
| B019ZANBS010 | K012232 | 000 |
| B019ZANBS01E0 | K012232 | 000 |
| B019ZANBT600 | K012232 | 000 |
| B019ZINBS45E0 | K012232 | 000 |
| B019ZINBS510 | K012232 | 000 |
| B019ZPIBG520 | K012232 | 000 |
| B019ZPIBS460 | K012232 | 000 |
| B019ZPNBG070 | K012232 | 000 |
| B019ZPNBG07E0 | K012232 | 000 |
| B019ZPNBS460 | K012232 | 000 |
| B019ZPNBS46E0 | K012232 | 000 |
| B019ZPNBS500 | K012232 | 000 |
| B019ZAIBS01E0 | K012232 | 000 |
| B019ZAIBS010 | K012232 | 000 |
| B019ZAIBL560 | K012232 | 000 |
| B019ULT1HI0 | K012232 | 000 |
| B019ULT1HPD0 | K012232 | 000 |
| B019ULT1HPI0 | K012232 | 000 |
| B019ULT1HSDD0 | K012232 | 000 |
| B019ULT1HSDI0 | K012232 | 000 |
| B019ULT1S0 | K012232 | 000 |
| B019ULT1SI0 | K012232 | 000 |
| B019ULT1SIA0 | K012232 | 000 |
| B019Z072000BA0 | K012232 | 000 |
| B019Z072000BB0 | K012232 | 000 |
| B019ZAIBD310 | K012232 | 000 |
| B019ZAIBG440 | K012232 | 000 |
| B019ZAIBG44E0 | K012232 | 000 |
| B019ZAIBL540 | K012232 | 000 |
| B019ZAIBL550 | K012232 | 000 |
| B019ZVU20160 | K012232 | 000 |