The following data is part of a premarket notification filed by Break Through, Inc. with the FDA for Iowa Oral Performance Isntrument.
| Device ID | K920091 |
| 510k Number | K920091 |
| Device Name: | IOWA ORAL PERFORMANCE ISNTRUMENT |
| Classification | Transducer, Miniature Pressure |
| Applicant | BREAK THROUGH, INC. 131 TECHNOLOGY INNOVATION CENT Oakdale, IA 52319 |
| Contact | Carolyn J Brown |
| Correspondent | Carolyn J Brown BREAK THROUGH, INC. 131 TECHNOLOGY INNOVATION CENT Oakdale, IA 52319 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-08 |
| Decision Date | 1992-05-20 |