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 |