The following data is part of a premarket notification filed by Neurocom International, Inc. with the FDA for Neurocom Pressure Test System.
| Device ID | K871652 |
| 510k Number | K871652 |
| Device Name: | NEUROCOM PRESSURE TEST SYSTEM |
| Classification | Tester, Auditory Impedance |
| Applicant | NEUROCOM INTERNATIONAL, INC. 9570 S.E. LAWNFIELD RD. Clackamas, OR 97015 |
| Contact | Jack Kelly |
| Correspondent | Jack Kelly NEUROCOM INTERNATIONAL, INC. 9570 S.E. LAWNFIELD RD. Clackamas, OR 97015 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-07-16 |