The following data is part of a premarket notification filed by Lucas Grason-stadler, Inc. with the FDA for Gsi 38 Auto Tymp.
| Device ID | K925585 |
| 510k Number | K925585 |
| Device Name: | GSI 38 AUTO TYMP |
| Classification | Tester, Auditory Impedance |
| Applicant | LUCAS GRASON-STADLER, INC. 537 GREAT RD. P.O. BOX 1400 Littleton, MA 01460 |
| Contact | Janice E Painter |
| Correspondent | Janice E Painter LUCAS 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 | 1992-11-04 |
| Decision Date | 1993-02-02 |