The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Vasomedical-biox Combined 12 Channel Ambulatory Ecg And Blood Pressure Recorder Model 2302, Vasomedical-biox Ambulatory.
| Device ID | K111096 |
| 510k Number | K111096 |
| Device Name: | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Contact | Richard E Gordon |
| Correspondent | Richard E Gordon VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817980020542 | K111096 | 000 |
| 00817980020528 | K111096 | 000 |
| 00817980020481 | K111096 | 000 |
| 00817980020474 | K111096 | 000 |
| 00817980020467 | K111096 | 000 |
| 00817980020085 | K111096 | 000 |
| 00817980020061 | K111096 | 000 |
| 00817980020054 | K111096 | 000 |
| 00817980020047 | K111096 | 000 |