The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for Ilo88 Otodynamic Analyzer Screening Audiometer.
Device ID | K890124 |
510k Number | K890124 |
Device Name: | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER |
Classification | Audiometer |
Applicant | GRASON-STADLER, INC. 537 GREAT RD., P.O. BOX 1400 Littleton, MA 01460 |
Contact | Janice E Painter |
Correspondent | Janice E Painter GRASON-STADLER, INC. 537 GREAT RD., P.O. BOX 1400 Littleton, MA 01460 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-11 |
Decision Date | 1989-07-14 |