The following data is part of a premarket notification filed by Lead-lok, Inc. with the FDA for Echo Gel (rainforest).
| Device ID | K895100 |
| 510k Number | K895100 |
| Device Name: | ECHO GEL (RAINFOREST) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | James Healy |
| Correspondent | James Healy LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-11-03 |