The following data is part of a premarket notification filed by Suntech Medical Instruments, Inc. with the FDA for Pressure Trak, Model 222-b.
| Device ID | K010622 |
| 510k Number | K010622 |
| Device Name: | PRESSURE TRAK, MODEL 222-B |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SUNTECH MEDICAL INSTRUMENTS, INC. 8917 GLENWOOD AVE. Raleigh, NC 27617 |
| Contact | David Gallick |
| Correspondent | David Gallick SUNTECH MEDICAL INSTRUMENTS, INC. 8917 GLENWOOD AVE. Raleigh, NC 27617 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-02 |
| Decision Date | 2001-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840935108368 | K010622 | 000 |
| 10840935102786 | K010622 | 000 |
| 10840935102779 | K010622 | 000 |
| 10840935102472 | K010622 | 000 |
| 10840935102465 | K010622 | 000 |
| 10840935102441 | K010622 | 000 |
| 10840935102434 | K010622 | 000 |
| 10840935102410 | K010622 | 000 |
| 10840935102403 | K010622 | 000 |
| 10840935102380 | K010622 | 000 |
| 10840935102793 | K010622 | 000 |
| 10840935105411 | K010622 | 000 |
| 10840935105428 | K010622 | 000 |
| 10840935108351 | K010622 | 000 |
| 10840935108344 | K010622 | 000 |
| 10840935108337 | K010622 | 000 |
| 10840935108320 | K010622 | 000 |
| 10840935106333 | K010622 | 000 |
| 10840935105503 | K010622 | 000 |
| 10840935105497 | K010622 | 000 |
| 10840935105473 | K010622 | 000 |
| 10840935105466 | K010622 | 000 |
| 10840935102373 | K010622 | 000 |