Emg Model 133

FDA 510(k) K842354 · Calnor of EL Paseo, Inc.

Substantially Equivalent

510(k) numberK842354

Submission

Device name
Emg Model 133
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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K122879EEGER4 Model 4.3HCC · Traditional Eeg Software, LLC02/06/2013SE
K111687Emg SystemHCC · Special Myotronics-Noromed, Inc.09/29/2011SE
K092675GrindcareHCC · Traditional Medotech A/S03/03/2010SE

More from Medotech A/S

510(k)DeviceDecision
K842353Temperature 132HCC · 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 Emg Model 133 cleared by the FDA?

Emg Model 133 (K842354) 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 K842354?

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