The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Venti-voice Nasal Catheter.
| Device ID | K834522 |
| 510k Number | K834522 |
| Device Name: | VENTI-VOICE NASAL CATHETER |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-01-17 |