Temperature 132

FDA 510(k) K842353 · Calnor of EL Paseo, Inc.

Substantially Equivalent

510(k) numberK842353

Submission

Device name
Temperature 132
Applicant
Calnor of EL Paseo, Inc.
Mchenry, IL, US
Received
May 7, 1984
Decision date
July 17, 1984
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

510(k)DeviceDecision
K842354Emg Model 133HCC · Traditional 07/17/1984SE
K842288EEG 130HCC · Traditional 07/17/1984SE
K841895GSR, 126, EEG 130-TEMP. 132, Emg 133HCC · Traditional 07/17/1984SE
K834152Ethylene Oxide Detector GLD-1-07FLE · Traditional 03/19/1984SE
K771577Clinical Emg Model 133HCC · Traditional 08/26/1977SE

Questions and answers

When was Temperature 132 cleared by the FDA?

Temperature 132 (K842353) received a 510(k) decision of Substantially Equivalent on July 17, 1984, 71 days after the submission was received.

What is the product code of K842353?

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