The following data is part of a premarket notification filed by General Hearing Instruments, Inc. with the FDA for Tranquil Tri-oe, Tranquil Tri-coe, Tranquil Tri-cic.
| Device ID | K974751 |
| 510k Number | K974751 |
| Device Name: | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC |
| Classification | Hearing Aid, Air Conduction |
| Applicant | GENERAL HEARING INSTRUMENTS, INC. 175 BROOKHOLLOW ESPL. Harahan, LA 70123 |
| Contact | Roger P Juneau |
| Correspondent | Roger P Juneau GENERAL HEARING INSTRUMENTS, INC. 175 BROOKHOLLOW ESPL. Harahan, LA 70123 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00089518000771 | K974751 | 000 |
| 00089518000627 | K974751 | 000 |
| 00089518000610 | K974751 | 000 |
| 00089518000603 | K974751 | 000 |
| 00089518000597 | K974751 | 000 |
| 00089518000580 | K974751 | 000 |
| 00089518000573 | K974751 | 000 |
| 00089518000566 | K974751 | 000 |
| 00089518000559 | K974751 | 000 |
| 00089518000542 | K974751 | 000 |
| 00089518000535 | K974751 | 000 |
| 00089518000528 | K974751 | 000 |
| 00089518000634 | K974751 | 000 |
| 00089518000641 | K974751 | 000 |
| 00089518000658 | K974751 | 000 |
| 00089518000764 | K974751 | 000 |
| 00089518000757 | K974751 | 000 |
| 00089518000740 | K974751 | 000 |
| 00089518000733 | K974751 | 000 |
| 00089518000726 | K974751 | 000 |
| 00089518000719 | K974751 | 000 |
| 00089518000702 | K974751 | 000 |
| 00089518000696 | K974751 | 000 |
| 00089518000689 | K974751 | 000 |
| 00089518000672 | K974751 | 000 |
| 00089518000665 | K974751 | 000 |
| 00089518000511 | K974751 | 000 |