The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Impedance Analyzer/audiometer Model Md-3.
| Device ID | K895784 |
| 510k Number | K895784 |
| Device Name: | IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 |
| Classification | Audiometer |
| Applicant | SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
| Contact | James I Beck |
| Correspondent | James I Beck SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1989-12-05 |