← FDA Medical Device Classifications
Intraocular, Pressure Measuring Device
NVB · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.4280
Classification
- FDA Product Code
NVB- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 886.4280
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown