The following data is part of a premarket notification filed by Mortara Instrument, Inc with the FDA for H3+ Holter Recorder.
| Device ID | K152626 |
| 510k Number | K152626 |
| Device Name: | H3+ Holter Recorder |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | MORTARA INSTRUMENT, INC 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Margaret Mucha |
| Correspondent | Margaret Mucha MORTARA INSTRUMENT, INC 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345025064 | K152626 | 000 |
| 00812345023077 | K152626 | 000 |
| 00812345023084 | K152626 | 000 |
| 00812345024982 | K152626 | 000 |
| 00812345024999 | K152626 | 000 |
| 00812345025002 | K152626 | 000 |
| 00812345025026 | K152626 | 000 |
| 00812345025033 | K152626 | 000 |
| 00812345025040 | K152626 | 000 |
| 00812345025057 | K152626 | 000 |
| 00732094282498 | K152626 | 000 |