The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 1859 Tumi/pressure Module.
| Device ID | K873695 |
| 510k Number | K873695 |
| Device Name: | MODEL 1859 TUMI/PRESSURE MODULE |
| Classification | Uroflowmeter |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Coats, M.d. |
| Correspondent | Coats, M.d. LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-14 |
| Decision Date | 1988-01-27 |