The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Phonatory Function Analyzer Ps-77.
| Device ID | K832678 |
| 510k Number | K832678 |
| Device Name: | PHONATORY FUNCTION ANALYZER PS-77 |
| Classification | Transducer, Gas Flow |
| Applicant | KELLS MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXP |
| CFR Regulation Number | 868.2885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-09 |
| Decision Date | 1984-03-07 |