The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Trach Vox.
| Device ID | K013728 |
| 510k Number | K013728 |
| Device Name: | TRACH VOX |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-09 |
| Decision Date | 2002-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841470101098 | K013728 | 000 |