The following data is part of a premarket notification filed by Argosy Electronics with the FDA for Manhattan 3-channel.
| Device ID | K934450 |
| 510k Number | K934450 |
| Device Name: | MANHATTAN 3-CHANNEL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie, MN 55344 |
| Contact | David A Preves |
| Correspondent | David A Preves ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie, MN 55344 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-10 |
| Decision Date | 1993-10-08 |