The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Combined Vasomedical-biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301.
| Device ID | K092785 |
| 510k Number | K092785 |
| Device Name: | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Contact | Richard Gordon |
| Correspondent | Richard Gordon 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 | 2009-09-10 |
| Decision Date | 2010-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817980020535 | K092785 | 000 |
| 00817980020245 | K092785 | 000 |
| 00817980020238 | K092785 | 000 |
| 00817980020221 | K092785 | 000 |
| 00817980020214 | K092785 | 000 |
| 00817980020207 | K092785 | 000 |
| 00817980020177 | K092785 | 000 |
| 00817980020122 | K092785 | 000 |
| 00817980020115 | K092785 | 000 |
| 00817980020108 | K092785 | 000 |
| 00817980020092 | K092785 | 000 |
| 00817980020252 | K092785 | 000 |
| 00817980020269 | K092785 | 000 |
| 00817980020511 | K092785 | 000 |
| 00817980020504 | K092785 | 000 |
| 00817980020498 | K092785 | 000 |
| 00817980020337 | K092785 | 000 |
| 00817980020320 | K092785 | 000 |
| 00817980020313 | K092785 | 000 |
| 00817980020306 | K092785 | 000 |
| 00817980020290 | K092785 | 000 |
| 00817980020283 | K092785 | 000 |
| 00817980020276 | K092785 | 000 |
| 00817980020078 | K092785 | 000 |