The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for H12+ Holter Recorder.
| Device ID | K050896 |
| 510k Number | K050896 |
| Device Name: | H12+ HOLTER RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-08 |
| Decision Date | 2005-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345024906 | K050896 | 000 |
| 00812345024883 | K050896 | 000 |
| 00812345024807 | K050896 | 000 |
| 00812345023060 | K050896 | 000 |
| 00812345022728 | K050896 | 000 |
| 00812345022711 | K050896 | 000 |