The following data is part of a premarket notification filed by Craigwell Electronics, Ltd. with the FDA for Craigwell Master Hearing Aid Mha.
| Device ID | K854126 |
| 510k Number | K854126 |
| Device Name: | CRAIGWELL MASTER HEARING AID MHA |
| Classification | Hearing Aid, Master |
| Applicant | CRAIGWELL ELECTRONICS, LTD. MEADOW VALE HOUSE LOWER BLUNSDON, NR SWINDON Wiltshire Sn2 4bj, GB |
| Contact | Wellburn |
| Correspondent | Wellburn CRAIGWELL ELECTRONICS, LTD. MEADOW VALE HOUSE LOWER BLUNSDON, NR SWINDON Wiltshire Sn2 4bj, GB |
| Product Code | KHL |
| CFR Regulation Number | 874.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1986-01-16 |