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 |