The following data is part of a premarket notification filed by Labtech Kft. with the FDA for Cardiospy Ecg Holter Systems.
| Device ID | K140847 |
| 510k Number | K140847 |
| Device Name: | CARDIOSPY ECG HOLTER SYSTEMS |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | LABTECH KFT. VAGU 4 Debrecen, HU 4031 |
| Contact | Zsolt Katonai |
| Correspondent | Zsolt Katonai LABTECH KFT. VAGU 4 Debrecen, HU 4031 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999883490075 | K140847 | 000 |
| 05999883490044 | K140847 | 000 |
| 05999883490013 | K140847 | 000 |
| 05999883490006 | K140847 | 000 |