The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-t/to And 650-s/so.
| Device ID | K043160 |
| 510k Number | K043160 |
| Device Name: | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | TRACOE MEDICAL GMBH 117 FLANDERS ROAD Westborough, MA 01581 |
| Contact | Michael A Warren |
| Correspondent | Michael A Warren TRACOE MEDICAL GMBH 117 FLANDERS ROAD Westborough, MA 01581 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035324054619 | K043160 | 000 |
| 04035324020157 | K043160 | 000 |
| 04035324020140 | K043160 | 000 |
| 04035324019151 | K043160 | 000 |
| 04035324012930 | K043160 | 000 |