510(k) K261725
- Device
- OtoCompanion (Version 1.0)
- Applicant
- Ironsides Medical, Inc.
- 510(k) number
- K261725
- Product code
- SHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-21
- Date received
- 2026-05-26
- Regulation
- 874.4775
- Classification name
- Ear, Nose, And Throat Image Analyzer
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daphne Psacharopoulos
- Address
- 1 Mifflin Pl. Cambridge MA US 02138 02138
FDA Registration Numbers#
- 3012678246
Source Documents#
Other 510(k) Records For Product Code SHL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | 2026-03-17 |