BREATH-EASY, MODIFICATION
Device Facts
| Record ID | K914416 |
|---|---|
| Device Name | BREATH-EASY, MODIFICATION |
| Applicant | Icor AB |
| Product Code | HME · Ophthalmic |
| Decision Date | Jun 23, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1140 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.
