SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
Device Facts
| Record ID | K950995 |
|---|---|
| Device Name | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | LYN · Ear, Nose, Throat |
| Decision Date | Jun 28, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.