The following data is part of a premarket notification filed by Phoenix Management, Inc. with the FDA for Hearing Aid (accessory).
| Device ID | K944009 |
| 510k Number | K944009 |
| Device Name: | HEARING AID (ACCESSORY) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | PHOENIX MANAGEMENT, INC. 5195 FONTAINE BLVD. Fountain, CO 80817 |
| Contact | Jo Waldron |
| Correspondent | Jo Waldron PHOENIX MANAGEMENT, INC. 5195 FONTAINE BLVD. Fountain, CO 80817 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-11-22 |