The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 1101m & 1151m Urolab Micro Urodynamic Record.
| Device ID | K863168 |
| 510k Number | K863168 |
| Device Name: | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Coats, Md |
| Correspondent | Coats, Md LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-18 |
| Decision Date | 1986-10-24 |