The following data is part of a premarket notification filed by Eco-med Pharmaceuticals, Inc. with the FDA for Ecogel 100 Ultrasound Gel.
| Device ID | K961757 |
| 510k Number | K961757 |
| Device Name: | ECOGEL 100 ULTRASOUND GEL |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario, CA L4w 1h3 |
| Contact | Paul L Hooey |
| Correspondent | Paul L Hooey ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario, CA L4w 1h3 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-06 |
| Decision Date | 1996-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055650386 | K961757 | 000 |
| 05060813630417 | K961757 | 000 |
| 05060813630424 | K961757 | 000 |
| 00628055650317 | K961757 | 000 |
| 00628055650324 | K961757 | 000 |
| 00628055650331 | K961757 | 000 |
| 00628055650348 | K961757 | 000 |
| 00628055650355 | K961757 | 000 |
| 00628055650362 | K961757 | 000 |
| 00628055650379 | K961757 | 000 |
| 05060813630400 | K961757 | 000 |