The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Holter Recorder H3+.
| Device ID | K043010 |
| 510k Number | K043010 |
| Device Name: | HOLTER RECORDER H3+ |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094320701 | K043010 | 000 |
| 00732094264241 | K043010 | 000 |
| 00732094264234 | K043010 | 000 |
| 00732094264227 | K043010 | 000 |
| 00732094264210 | K043010 | 000 |
| 00732094264203 | K043010 | 000 |
| 00732094264197 | K043010 | 000 |
| 00732094264180 | K043010 | 000 |
| 00732094264173 | K043010 | 000 |
| 00732094264166 | K043010 | 000 |
| 00732094264159 | K043010 | 000 |
| 00732094264142 | K043010 | 000 |
| 00732094264135 | K043010 | 000 |
| 00732094257786 | K043010 | 000 |
| 00732094264258 | K043010 | 000 |
| 00732094264265 | K043010 | 000 |
| 00732094264272 | K043010 | 000 |
| 00732094308563 | K043010 | 000 |
| 00732094308556 | K043010 | 000 |
| 00732094264388 | K043010 | 000 |
| 00732094264371 | K043010 | 000 |
| 00732094264364 | K043010 | 000 |
| 00732094264357 | K043010 | 000 |
| 00732094264340 | K043010 | 000 |
| 00732094264333 | K043010 | 000 |
| 00732094264326 | K043010 | 000 |
| 00732094264319 | K043010 | 000 |
| 00732094264302 | K043010 | 000 |
| 00732094264296 | K043010 | 000 |
| 00732094264289 | K043010 | 000 |
| 00817655020853 | K043010 | 000 |