The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-green, Integre Pro Scan Red-yellow.
| Device ID | K142398 |
| 510k Number | K142398 |
| Device Name: | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow |
| Classification | Laser, Ophthalmic |
| Applicant | Ellex Medical Pty. Ltd. 82 GILBERT ST. Adelaide, AU 5000 |
| Contact | Kevin Howard |
| Correspondent | Kevin Howard Ellex Medical Pty. Ltd. 82 GILBERT ST. Adelaide, AU 5000 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2015-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000267 | K142398 | 000 |
| 09342395000243 | K142398 | 000 |
| 09342395000168 | K142398 | 000 |
| 09342395000151 | K142398 | 000 |
| 09342395000144 | K142398 | 000 |