The following data is part of a premarket notification filed by Global Instrumentation, Llc with the FDA for Matrix Holter System, Model M12.
| Device ID | K051730 |
| 510k Number | K051730 |
| Device Name: | MATRIX HOLTER SYSTEM, MODEL M12 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD Manlius, NY 13104 |
| Contact | Craig Sellers |
| Correspondent | Craig Sellers GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD Manlius, NY 13104 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-27 |
| Decision Date | 2005-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094128482 | K051730 | 000 |
| 90815187020283 | K051730 | 000 |
| 90815187020276 | K051730 | 000 |
| 90815187020269 | K051730 | 000 |
| 90815187020252 | K051730 | 000 |
| 90815187020245 | K051730 | 000 |
| 90815187020221 | K051730 | 000 |
| 90815187020214 | K051730 | 000 |
| 90815187020191 | K051730 | 000 |
| 90815187020184 | K051730 | 000 |
| 90815187020177 | K051730 | 000 |
| 90815187020160 | K051730 | 000 |
| 90815187020153 | K051730 | 000 |
| 90815187020146 | K051730 | 000 |
| 90815187020139 | K051730 | 000 |
| 90815187020122 | K051730 | 000 |
| 90815187020719 | K051730 | 000 |
| 90815187020702 | K051730 | 000 |
| 90815187020290 | K051730 | 000 |
| 90815187020313 | K051730 | 000 |
| 00732094128444 | K051730 | 000 |
| 00732094070736 | K051730 | 000 |
| 00732094070729 | K051730 | 000 |
| 00732094070712 | K051730 | 000 |
| 00732094070705 | K051730 | 000 |
| 00732094053326 | K051730 | 000 |
| 00732094053319 | K051730 | 000 |
| 00732094053081 | K051730 | 000 |
| 00732094052435 | K051730 | 000 |
| 90815187020429 | K051730 | 000 |
| 90815187020399 | K051730 | 000 |
| 90815187020382 | K051730 | 000 |
| 90815187020375 | K051730 | 000 |
| 90815187020351 | K051730 | 000 |
| 90815187020344 | K051730 | 000 |
| 90815187020337 | K051730 | 000 |
| 90815187020320 | K051730 | 000 |
| 90815187020696 | K051730 | 000 |