Device |
intraocular, pressure measuring device |
Regulation Description |
Intraocular pressure measuring device. |
Definition |
Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma. |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | NVB |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
PMA
|
Regulation Number |
886.4280
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|