IOWA ORAL PERFORMANCE ISNTRUMENT
Device Facts
| Record ID | K920091 |
|---|---|
| Device Name | IOWA ORAL PERFORMANCE ISNTRUMENT |
| Applicant | Breakthrough, Inc. |
| Product Code | IKE · Physical Medicine |
| Decision Date | May 20, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1615 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.