The following data is part of a premarket notification filed by Bq Plus Medical Co., Ltd. with the FDA for I.v. Administration Set.
Device ID | K210381 |
510k Number | K210381 |
Device Name: | I.V. Administration Set |
Classification | Set, Administration, Intravascular |
Applicant | BQ PLUS Medical Co., Ltd. No. 18, Cheye Road, Chedun Town, Songjiang Shanghai, CN 201611 |
Contact | Jin Zhang |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-09 |
Decision Date | 2021-08-14 |