The following data is part of a premarket notification filed by Black Diamond Video, Inc with the FDA for Idss Forcetriad Control Module.
| Device ID | K153205 |
| 510k Number | K153205 |
| Device Name: | IDSS ForceTriad Control Module |
| Classification | Endoscopic Central Control Unit |
| Applicant | BLACK DIAMOND VIDEO, INC 503 CANAL BLVD Richmond, CA 94804 |
| Contact | Ragunath Muniandy |
| Correspondent | Ragunath Muniandy BLACK DIAMOND VIDEO, INC 503 CANAL BLVD Richmond, CA 94804 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-04 |
| Decision Date | 2016-08-01 |
| Summary: | summary |