The following data is part of a premarket notification filed by Suntech Medical, Inc. with the FDA for Tango+ Automatic Blood Pressure And Oxygen Saturation Measurement System.
| Device ID | K053209 |
| 510k Number | K053209 |
| Device Name: | TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SUNTECH MEDICAL, INC. 377 ROUTE 17 Hasbrouck Heights, NJ 07460 |
| Contact | George Myers |
| Correspondent | George Myers SUNTECH MEDICAL, INC. 377 ROUTE 17 Hasbrouck Heights, NJ 07460 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2006-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840935102755 | K053209 | 000 |
| 10840935109372 | K053209 | 000 |
| 10840935109389 | K053209 | 000 |