The following data is part of a premarket notification filed by Craigwell Electronics, Ltd. with the FDA for Craigwell Aid Fitting System Afs.
| Device ID | K854125 |
| 510k Number | K854125 |
| Device Name: | CRAIGWELL AID FITTING SYSTEM AFS |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1986-01-16 |