The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Audiometer Da 323.
Device ID | K933222 |
510k Number | K933222 |
Device Name: | AUDIOMETER DA 323 |
Classification | Audiometer |
Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
Contact | Michael Davidson |
Correspondent | Michael Davidson FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-01 |
Decision Date | 1993-11-01 |