The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for Middle Ear Analyzer (impedance Audiometer).
| Device ID | K863353 |
| 510k Number | K863353 |
| Device Name: | MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) |
| Classification | Tester, Auditory Impedance |
| 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 | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-29 |
| Decision Date | 1986-11-03 |