The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Cavrolab.
| Device ID | K882585 |
| 510k Number | K882585 |
| Device Name: | CAVROLAB |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| 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 | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1989-03-02 |