CUFFALERT
Cuff, Tracheal Tube, Inflatable
SUNMED
The following data is part of a premarket notification filed by Sunmed with the FDA for Cuffalert.
Pre-market Notification Details
| Device ID | K081805 |
| 510k Number | K081805 |
| Device Name: | CUFFALERT |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | SUNMED 24301 WOODSAGE DR. Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SUNMED 24301 WOODSAGE DR. Bonita Springs, FL 34134 -2958 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
Trademark Results [CUFFALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUFFALERT 77387851 3495770 Dead/Cancelled |
SUNMED, LLC 2008-02-04 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.