The following data is part of a premarket notification filed by Medcare Flaga with the FDA for Universal Xacttrace.
| Device ID | K043132 |
| 510k Number | K043132 |
| Device Name: | UNIVERSAL XACTTRACE |
| Classification | Ventilatory Effort Recorder |
| Applicant | MEDCARE FLAGA SIDUMULI 24 Reykjavik, IS Is 108 |
| Contact | Kolbrun E Ottosdottir |
| Correspondent | Kolbrun E Ottosdottir MEDCARE FLAGA SIDUMULI 24 Reykjavik, IS Is 108 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2004-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830027229 | K043132 | 000 |
| 00382830027205 | K043132 | 000 |
| 00382830026277 | K043132 | 000 |
| 00382830027076 | K043132 | 000 |
| 00382830027083 | K043132 | 000 |
| 00382830027090 | K043132 | 000 |
| 00382830027106 | K043132 | 000 |
| 00382830027113 | K043132 | 000 |
| 00382830027120 | K043132 | 000 |
| 00382830027137 | K043132 | 000 |
| 00382830027144 | K043132 | 000 |
| 00382830027151 | K043132 | 000 |
| 00382830027168 | K043132 | 000 |
| 00382830027175 | K043132 | 000 |
| 00382830027182 | K043132 | 000 |
| 00382830027199 | K043132 | 000 |
| 00382830025973 | K043132 | 000 |