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FDA 510(k)

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger

K-Number: K211589 · 2022-01-27

ApplicantRemington Medical, Inc.
Decision Date2022-01-27
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger is a medical device manufactured by Remington Medical, Inc.. It received FDA 510(k) clearance on 2022-01-27 under approval number K211589. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger?

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Remington Medical, Inc.. The 510(k) number is K211589.

When was VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger approved by the FDA?

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger received FDA 510(k) clearance on 2022-01-27, under approval number K211589.

What company makes VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger?

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger is manufactured by Remington Medical, Inc..

What is the FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger?

The FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger is DPW.

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Other Devices by Remington Medical, Inc.

K191315Remington Medical, Inc. Automatic Cutting Needle (NAC) K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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