The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Pg-800a Series.
| Device ID | K131569 |
| 510k Number | K131569 |
| Device Name: | PG-800A SERIES |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN PANGO ELECTRONIC CO., LTD P.O. BOX 237-023 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-30 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00739810204208 | K131569 | 000 |
| 06948423800484 | K131569 | 000 |
| 06948423800477 | K131569 | 000 |
| 06948423800460 | K131569 | 000 |
| 06948423800453 | K131569 | 000 |
| 06948423800446 | K131569 | 000 |
| 06948423800439 | K131569 | 000 |
| 06948423800422 | K131569 | 000 |
| 06948423800415 | K131569 | 000 |
| 10898302140114 | K131569 | 000 |
| 06948423800491 | K131569 | 000 |
| 06948423800507 | K131569 | 000 |
| 06948423800514 | K131569 | 000 |
| 00864243000407 | K131569 | 000 |
| 06951740514514 | K131569 | 000 |
| 06948423800583 | K131569 | 000 |
| 06948423800576 | K131569 | 000 |
| 06948423800569 | K131569 | 000 |
| 06948423800552 | K131569 | 000 |
| 06948423800545 | K131569 | 000 |
| 06948423800538 | K131569 | 000 |
| 06948423800521 | K131569 | 000 |
| 00850033118162 | K131569 | 000 |