The following data is part of a premarket notification filed by I2s Micro Implantable Systems, Llc with the FDA for Blackrock Neuroport Biopotential Signal Processing System.
| Device ID | K090957 |
| 510k Number | K090957 |
| Device Name: | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM |
| Classification | Amplifier, Physiological Signal |
| Applicant | I2S MICRO IMPLANTABLE SYSTEMS, LLC 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring I2S MICRO IMPLANTABLE SYSTEMS, LLC 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814901020315 | K090957 | 000 |
| 00814901020186 | K090957 | 000 |
| 00814901020179 | K090957 | 000 |
| 00814901020162 | K090957 | 000 |
| 00814901020155 | K090957 | 000 |
| 00814901020148 | K090957 | 000 |
| 00814901020131 | K090957 | 000 |
| 00814901020124 | K090957 | 000 |
| 00814901020117 | K090957 | 000 |
| 00814901020100 | K090957 | 000 |
| 00814901021428 | K090957 | 000 |
| 00814901020193 | K090957 | 000 |
| 00814901020209 | K090957 | 000 |
| 00814901020308 | K090957 | 000 |
| 00814901020292 | K090957 | 000 |
| 00814901020285 | K090957 | 000 |
| 00814901020278 | K090957 | 000 |
| 00814901020261 | K090957 | 000 |
| 00814901020254 | K090957 | 000 |
| 00814901020247 | K090957 | 000 |
| 00814901020230 | K090957 | 000 |
| 00814901020223 | K090957 | 000 |
| 00814901020216 | K090957 | 000 |
| 00814901021459 | K090957 | 000 |