The following data is part of a premarket notification filed by Optoacoustics Ltd with the FDA for Mri Multi-channel Optical Communication (moc) System Imroc/imroc Ir Wirless Optoactive.
| Device ID | K121239 |
| 510k Number | K121239 |
| Device Name: | MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | OPTOACOUSTICS LTD 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OPTOACOUSTICS LTD 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290019141006 | K121239 | 000 |