The following data is part of a premarket notification filed by Vales & Hills Biomedical Tech. Ltd. with the FDA for Cv3000 Holter Analysis System.
| Device ID | K131897 |
| 510k Number | K131897 |
| Device Name: | CV3000 HOLTER ANALYSIS SYSTEM |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | VALES & HILLS BIOMEDICAL TECH. LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong VALES & HILLS BIOMEDICAL TECH. LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-11-26 |
| Summary: | summary |