Device Type ID | 5538 |
Device Name | Camera, Television, Microsurgical, With Audio |
Regulation Description | Surgical Camera And Accessories. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.4160 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FWE |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5538 |
Device | Camera, Television, Microsurgical, With Audio |
Product Code | FWE |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Surgical Camera And Accessories. |
CFR Regulation Number | 878.4160 [🔎] |