Device Type ID | 4280 |
Device Name | Locator, Metal, Electronic |
Regulation Description | Electronic Metal Locator. |
Regulation Medical Specialty | Ophthalmic |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 886.4400 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HPM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 4280 |
Device | Locator, Metal, Electronic |
Product Code | HPM |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Electronic Metal Locator. |
CFR Regulation Number | 886.4400 [🔎] |