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 |