The following data is part of a premarket notification filed by Pulse Medical Instruments with the FDA for Pupil Pathway Analyzer (ppa).
| Device ID | K895609 |
| 510k Number | K895609 |
| Device Name: | PUPIL PATHWAY ANALYZER (PPA) |
| Classification | Pupillometer, Ac-powered |
| Applicant | PULSE MEDICAL INSTRUMENTS 130 MCCORMICK AVE. STE 112 COSTA MESA, CA 92626 |
| Contact | JUDY C LINDSTROM |
| Correspondent | JUDY C LINDSTROM PULSE MEDICAL INSTRUMENTS 130 MCCORMICK AVE. STE 112 COSTA MESA, CA 92626 |
| Product Code | HLG |
| CFR Regulation Number | 886.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1989-11-02 |