The following data is part of a premarket notification filed by Embla Systems with the FDA for Xacttrace Single Use Respiratory Effort Belt System.
| Device ID | K173793 |
| 510k Number | K173793 |
| Device Name: | XactTrace Single Use Respiratory Effort Belt System |
| Classification | Ventilatory Effort Recorder |
| Applicant | Embla Systems 1 Hines Road, Suite 202 Kanata, CA K2k 3c7 |
| Contact | Sanjay Mehta |
| Correspondent | Sanjay Mehta Embla Systems 1 Hines Road, Suite 202 Kanata, CA K2k 3c7 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2019-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830047708 | K173793 | 000 |
| 00382830025928 | K173793 | 000 |
| 00382830025935 | K173793 | 000 |
| 00382830025942 | K173793 | 000 |
| 00382830026222 | K173793 | 000 |
| 00382830026239 | K173793 | 000 |
| 00382830026246 | K173793 | 000 |
| 00382830026253 | K173793 | 000 |
| 00382830026260 | K173793 | 000 |
| 00382830026284 | K173793 | 000 |
| 00382830026291 | K173793 | 000 |
| 00382830047456 | K173793 | 000 |
| 00382830047463 | K173793 | 000 |
| 00382830057585 | K173793 | 000 |