The following data is part of a premarket notification filed by Methodsense, Inc. with the FDA for Ndohd High Definition Imaging System (ndohd).
| Device ID | K131873 |
| 510k Number | K131873 |
| Device Name: | NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) |
| Classification | System, Image Processing, Radiological |
| Applicant | METHODSENSE, INC. P.O. BOX 110352 Durham, NC 27709 |
| Contact | Rita King |
| Correspondent | Rita King METHODSENSE, INC. P.O. BOX 110352 Durham, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2013-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866861000203 | K131873 | 000 |