The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Pg-800b Series, Including Pg-800bd, Pg-800b-1, Pg-800bd-1, Pg-800b3, Pg-800b4, Pg-800b4d, Pg-800b5, Pg-800b5-1, Pg-800b6.
| Device ID | K131558 |
| 510k Number | K131558 |
| Device Name: | PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN PANGO ELECTRONIC CO., LTD XIKENG VILLAGE, HENGGANG TOWN, LONGGANG DISTRICT Zhenzhen, Guangdong, CN 518115 |
| Contact | Xiaoyun Yang |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| 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 | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00739810210988 | K131558 | 000 |
| 06948423800118 | K131558 | 000 |
| 06948423800101 | K131558 | 000 |
| 06948423800095 | K131558 | 000 |
| 06948423800088 | K131558 | 000 |
| 06948423800071 | K131558 | 000 |
| 06948423800064 | K131558 | 000 |
| 06948423800057 | K131558 | 000 |
| 06948423800040 | K131558 | 000 |
| 06948423800033 | K131558 | 000 |
| 06948423800026 | K131558 | 000 |
| 06948423800019 | K131558 | 000 |
| 00860002217208 | K131558 | 000 |
| 06948423800125 | K131558 | 000 |
| 06948423800132 | K131558 | 000 |
| 00739810210971 | K131558 | 000 |
| 00739810210704 | K131558 | 000 |
| 00739810210698 | K131558 | 000 |
| 00815802014465 | K131558 | 000 |
| 20815802014452 | K131558 | 000 |
| 00860000853125 | K131558 | 000 |
| 06948423800194 | K131558 | 000 |
| 06948423800187 | K131558 | 000 |
| 06948423800170 | K131558 | 000 |
| 06948423800163 | K131558 | 000 |
| 06948423800156 | K131558 | 000 |
| 06948423800149 | K131558 | 000 |
| 00850033118155 | K131558 | 000 |