The following data is part of a premarket notification filed by Frye Electronics, Inc. with the FDA for Type 6400 Real Ear Hearing Aid Analyzer.
| Device ID | K872242 |
| 510k Number | K872242 |
| Device Name: | TYPE 6400 REAL EAR HEARING AID ANALYZER |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | FRYE ELECTRONICS, INC. P.O. BOX 23391 9826 S.W. TIGARD ST. Tigard, OR 97223 |
| Contact | George J Frye |
| Correspondent | George J Frye FRYE ELECTRONICS, INC. P.O. BOX 23391 9826 S.W. TIGARD ST. Tigard, OR 97223 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-11 |
| Decision Date | 1987-07-10 |