The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Electronic Blood Pressure Monitor.
Device ID | K102920 |
510k Number | K102920 |
Device Name: | ELECTRONIC BLOOD PRESSURE 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 | 2010-10-01 |
Decision Date | 2010-10-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06948423800408 | K102920 | 000 |
00856324008310 | K102920 | 000 |