The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Vasomedical-biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-biox 3- Channel Miniature Ambulatory.
| Device ID | K111180 |
| 510k Number | K111180 |
| Device Name: | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE 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 | 2011-04-27 |
| Decision Date | 2011-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817980020672 | K111180 | 000 |
| 00817980020436 | K111180 | 000 |
| 00817980020399 | K111180 | 000 |
| 00817980020382 | K111180 | 000 |
| 00817980020191 | K111180 | 000 |
| 00817980020184 | K111180 | 000 |
| 00817980020160 | K111180 | 000 |
| 00817980020153 | K111180 | 000 |
| 00817980020146 | K111180 | 000 |
| 00817980020139 | K111180 | 000 |
| 00817980020030 | K111180 | 000 |
| 00817980020023 | K111180 | 000 |
| 00817980020443 | K111180 | 000 |
| 00817980020450 | K111180 | 000 |
| 00817980020559 | K111180 | 000 |
| 00817980020665 | K111180 | 000 |
| 00817980020658 | K111180 | 000 |
| 00817980020641 | K111180 | 000 |
| 00817980020634 | K111180 | 000 |
| 00817980020627 | K111180 | 000 |
| 00817980020610 | K111180 | 000 |
| 00817980020603 | K111180 | 000 |
| 00817980020597 | K111180 | 000 |
| 00817980020580 | K111180 | 000 |
| 00817980020573 | K111180 | 000 |
| 00817980020566 | K111180 | 000 |
| 00817980020016 | K111180 | 000 |