The following data is part of a premarket notification filed by Pmd Solutions with the FDA for Respirasense.
| Device ID | K220111 |
| 510k Number | K220111 |
| Device Name: | RespiraSense |
| Classification | Monitor, Breathing Frequency |
| Applicant | PMD Solutions Bishopstown House Model Farm Rd Cork, IE T12 T922 |
| Contact | Sinead O'Sullivan |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-13 |
| Decision Date | 2022-10-07 |