The following data is part of a premarket notification filed by Engineered Medical Systems, Inc. with the FDA for Talking Trach.
| Device ID | K062104 |
| 510k Number | K062104 |
| Device Name: | TALKING TRACH |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | ENGINEERED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK # 102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ENGINEERED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK # 102 Bonita Springs, FL 34134 -2015 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2007-04-20 |
| Summary: | summary |