Nicolet Versalab

FDA 510(k) K010521 · Nicolet Biomedical

Substantially Equivalent

510(k) numberK010521

Submission

Device name
Nicolet Versalab
Applicant
Nicolet Biomedical
Golden, CO, US
Received
February 22, 2001
Decision date
March 9, 2001
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAF – Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Specialty
Radiology

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More from Multigon Industries, Inc.

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K020754Nicolet Pioneer TC8080IYN · Abbreviated 04/21/2003SE
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K020218Snap EEG MonitorOLW · Abbreviated 04/22/2002SE
K013281Versalab ApmHGM · Abbreviated 04/18/2002SE
K020955Nicolet Electrocautery DetectorETN · Abbreviated 04/17/2002SE
K013419Nicolet Electromagnetic Navigation SystemLLZ · Traditional 12/20/2001SE
K011823Biorehab SystemHCC · Abbreviated 09/06/2001SE
K011818Sterile Emg ElectrodesIKT · Abbreviated 09/06/2001SE
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Questions and answers

When was Nicolet Versalab cleared by the FDA?

Nicolet Versalab (K010521) received a 510(k) decision of Substantially Equivalent on March 9, 2001, 15 days after the submission was received.

What is the product code of K010521?

The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.