The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Anorectal Manometry Software Option Arm-1.
| Device ID | K082056 |
| 510k Number | K082056 |
| Device Name: | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2008-11-07 |