T824 Temperature Monitor

FDA 510(k) K880914 · Bio-Logic Devices

Substantially Equivalent

510(k) numberK880914

Submission

Device name
T824 Temperature Monitor
Applicant
Bio-Logic Devices
Deer Park, NY, US
Received
March 3, 1988
Decision date
May 11, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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More from Medotech A/S

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K880916M444 Emg MonitorHCC · Traditional 05/11/1988SE
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Questions and answers

When was T824 Temperature Monitor cleared by the FDA?

T824 Temperature Monitor (K880914) received a 510(k) decision of Substantially Equivalent on May 11, 1988, 69 days after the submission was received.

What is the product code of K880914?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.