The following data is part of a premarket notification filed by Eckstein Brothers, Inc. with the FDA for Model Eb-22 Noise Stik.
| Device ID | K895200 |
| 510k Number | K895200 |
| Device Name: | MODEL EB-22 NOISE STIK |
| Classification | Audiometer |
| Applicant | ECKSTEIN BROTHERS, INC. 4807 WEST 118TH PLACE Hawthorne (l.a.), CA 90250 |
| Contact | Leo H Eckstein |
| Correspondent | Leo H Eckstein ECKSTEIN BROTHERS, INC. 4807 WEST 118TH PLACE Hawthorne (l.a.), CA 90250 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-18 |
| Decision Date | 1990-01-22 |