The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Electronic Blood Presure Monitor.
| Device ID | K102988 |
| 510k Number | K102988 |
| Device Name: | ELECTRONIC BLOOD PRESURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN PANGO ELECTRONIC CO., LTD P.O. BOX 237-023 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2010-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00739810210599 | K102988 | 000 |
| 06948423800002 | K102988 | 000 |