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FDA 510(k)

GSR, 126, EEG 130-TEMP. 132, EMG 133

K-Number: K841895 · 1984-07-17

ApplicantCalnor of EL Paseo, Inc.
Decision Date1984-07-17
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GSR, 126, EEG 130-TEMP. 132, EMG 133 is the device name listed in this FDA 510(k) record. The listed applicant is Calnor of EL Paseo, Inc.. It received FDA 510(k) clearance on 1984-07-17 under 510(k) number K841895. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSR, 126, EEG 130-TEMP. 132, EMG 133?

GSR, 126, EEG 130-TEMP. 132, EMG 133 is a medical device that received FDA 510(k) clearance on 1984-07-17. The listed applicant is Calnor of EL Paseo, Inc.. The 510(k) number is K841895.

When did GSR, 126, EEG 130-TEMP. 132, EMG 133 receive FDA 510(k) clearance?

GSR, 126, EEG 130-TEMP. 132, EMG 133 received FDA 510(k) clearance on 1984-07-17, under 510(k) number K841895.

Who is the listed applicant for GSR, 126, EEG 130-TEMP. 132, EMG 133?

The FDA 510(k) record lists Calnor of EL Paseo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSR, 126, EEG 130-TEMP. 132, EMG 133?

The FDA product code for GSR, 126, EEG 130-TEMP. 132, EMG 133 is HCC.

Other records listing Calnor of EL Paseo, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K842288EEG 130K842353TEMPERATURE 132K842354EMG MODEL 133K834152ETHYLENE OXIDE DETECTOR GLD-1-07K771577CLINICAL EMG MODEL 133

Related Devices (Code: HCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

Official Source

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