Device Type ID | 5721 |
Device Name | Chamber, Oxygen, Topical, Extremity |
Regulation Description | Topical Oxygen Chamber For Extremities. |
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 One - Light Based/Laser (GSDB1) |
Submission Type | 510(k) |
CFR Regulation Number | 878.5650 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KPJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5721 |
Device | Chamber, Oxygen, Topical, Extremity |
Product Code | KPJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Topical Oxygen Chamber For Extremities. |
CFR Regulation Number | 878.5650 [🔎] |