The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Vascuchek Kit, Vascuchek Transceiver, Vascuchek Clinical Probe, Vascuchek Charger.
Device ID | K212065 |
510k Number | K212065 |
Device Name: | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 |
Contact | Caitlin Senter |
Correspondent | C. Matt Brown Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-02 |
Decision Date | 2021-10-07 |