The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for H12+holter Recorder.
| Device ID | K021373 |
| 510k Number | K021373 |
| Device Name: | H12+HOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Harlan L Van Matre |
| Correspondent | Harlan L Van Matre MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-01 |
| Decision Date | 2002-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094309300 | K021373 | 000 |
| 00732094327779 | K021373 | 000 |
| 00732094327786 | K021373 | 000 |
| 00732094327793 | K021373 | 000 |
| 00732094327410 | K021373 | 000 |
| 00732094264838 | K021373 | 000 |
| 00732094294118 | K021373 | 000 |
| 00732094309270 | K021373 | 000 |
| 00732094309287 | K021373 | 000 |
| 00732094309294 | K021373 | 000 |
| 00732094327762 | K021373 | 000 |