The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd with the FDA for Fetal Doppler Jpd-100s.
Device ID | K110124 |
510k Number | K110124 |
Device Name: | FETAL DOPPLER JPD-100S |
Classification | Monitor, Ultrasonic, Fetal |
Applicant | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
Contact | Diana Hong |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | KNG |
CFR Regulation Number | 884.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-01-18 |
Decision Date | 2011-02-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00864243000414 | K110124 | 000 |
06951740500012 | K110124 | 000 |
06951740500029 | K110124 | 000 |
06951740500036 | K110124 | 000 |
06951740500043 | K110124 | 000 |
06951740522137 | K110124 | 000 |
06951740522397 | K110124 | 000 |
06951740522403 | K110124 | 000 |
06951740522526 | K110124 | 000 |
10861910000309 | K110124 | 000 |
06951740500005 | K110124 | 000 |