The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Md5 Automatic Audiometer.
Device ID | K896909 |
510k Number | K896909 |
Device Name: | MD5 AUTOMATIC AUDIOMETER |
Classification | Audiometer |
Applicant | SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
Contact | James W Schwartz |
Correspondent | James W Schwartz 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 | 1989-12-11 |
Decision Date | 1990-03-05 |