The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Dx Center:impedance Test W/rhino & Audio Opt.
| Device ID | K883293 |
| 510k Number | K883293 |
| Device Name: | STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT |
| Classification | Tester, Auditory Impedance |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dan Regan |
| Correspondent | Dan Regan STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-04 |
| Decision Date | 1989-06-09 |