The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Vasomedical Biox Cb-1305-c, 3 Channel Ecg Holter Monitor, Model Cb-1305-c.
| Device ID | K083820 |
| 510k Number | K083820 |
| Device Name: | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Contact | Melissa Purpura |
| Correspondent | Melissa Purpura VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-04-01 |
| Summary: | summary |