The following data is part of a premarket notification filed by Intricon Datrix Corporation with the FDA for Intricon Datrix Sirona Event/ Holter Recorder.
| Device ID | K112601 |
| 510k Number | K112601 |
| Device Name: | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | INTRICON DATRIX CORPORATION 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Tanya O'brien |
| Correspondent | Tanya O'brien INTRICON DATRIX CORPORATION 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2011-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851074007378 | K112601 | 000 |
| 00851074007392 | K112601 | 000 |
| 00851074007200 | K112601 | 000 |
| 00851074007262 | K112601 | 000 |
| 00851074007293 | K112601 | 000 |
| 00851074007323 | K112601 | 000 |
| 00851074007330 | K112601 | 000 |
| 00851074007347 | K112601 | 000 |
| 00851074007354 | K112601 | 000 |
| 00851074007385 | K112601 | 000 |