The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe Cuff Pressure Monitor.
| Device ID | K152778 |
| 510k Number | K152778 |
| Device Name: | TRACOE Cuff Pressure Monitor |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | TRACOE MEDICAL GMBH REICHELSHEIMER STR. 1/3 Nieder-olm, DE D-55268 |
| Contact | Stephan Kohler |
| Correspondent | Eva Schaeffer AJW TECHNOLOGY CONSULTANTS, INC. Reichelsheimer Str. 1/3 Nieder-olm, GE D-55268 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035324046317 | K152778 | 000 |