The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Iop8 Intra Operative Probe.
| Device ID | K032315 |
| 510k Number | K032315 |
| Device Name: | IOP8 INTRA OPERATIVE PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Contact | B.j. Colleypriest |
| Correspondent | B.j. Colleypriest HUNTLEIGH HEALTHCARE, INC. 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 | 2003-07-28 |
| Decision Date | 2004-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968022981 | K032315 | 000 |
| 05051968020536 | K032315 | 000 |
| 05051968020482 | K032315 | 000 |
| 05051968020161 | K032315 | 000 |
| 05051968020154 | K032315 | 000 |
| 05051968041388 | K032315 | 000 |
| 05051968041371 | K032315 | 000 |