The following data is part of a premarket notification filed by Infinitt Co., Ltd. with the FDA for Rapidiacolon.
| Device ID | K041761 |
| 510k Number | K041761 |
| Device Name: | RAPIDIACOLON |
| Classification | System, Image Processing, Radiological |
| Applicant | INFINITT CO., LTD. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | N.e. Devine, Jr. ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-30 |
| Decision Date | 2004-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790024 | K041761 | 000 |