The following data is part of a premarket notification filed by Huntleigh Healthcare Limited with the FDA for Disposable Intraoperative Probe (diop8).
| Device ID | K201425 |
| 510k Number | K201425 |
| Device Name: | Disposable Intraoperative Probe (DIOP8) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
| Contact | Steve Monks |
| Correspondent | Steve Monks Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968041852 | K201425 | 000 |
| 05051968036544 | K201425 | 000 |
| 05051968032317 | K201425 | 000 |