The following data is part of a premarket notification filed by Lerado China Limited with the FDA for Leradotech Scooter, Model Sb.
Device ID | K070817 |
510k Number | K070817 |
Device Name: | LERADOTECH SCOOTER, MODEL SB |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | LERADO CHINA LIMITED NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen LERADO CHINA LIMITED NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-26 |
Decision Date | 2007-04-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00822383984032 | K070817 | 000 |
06973134780107 | K070817 | 000 |
00822383284736 | K070817 | 000 |
00822383284750 | K070817 | 000 |
00822383284767 | K070817 | 000 |
50822383284212 | K070817 | 000 |
50822383284236 | K070817 | 000 |
50822383284748 | K070817 | 000 |
00822383284200 | K070817 | 000 |
00822383284224 | K070817 | 000 |
00822383284705 | K070817 | 000 |
00822383984025 | K070817 | 000 |
06973134780091 | K070817 | 000 |