The following data is part of a premarket notification filed by Teleflex Medical, Inc with the FDA for Hudson Rci Voldyne Volumetric Exerciser.
| Device ID | K182847 |
| 510k Number | K182847 |
| Device Name: | Hudson RCI Voldyne Volumetric Exerciser |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Teleflex Medical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 |
| Contact | Sirisha Kommana |
| Correspondent | Sirisha Kommana Teleflex Medical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2019-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704615234 | K182847 | 000 |
| 24026704615227 | K182847 | 000 |
| 24026704615210 | K182847 | 000 |
| 24026704615265 | K182847 | 000 |
| 24026704615258 | K182847 | 000 |