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FDA 510(k)

TEMPERATURE 132

K-Number: K842353 · 1984-07-17

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

Device Summary

TEMPERATURE 132 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 K842353. 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 TEMPERATURE 132?

TEMPERATURE 132 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 K842353.

When did TEMPERATURE 132 receive FDA 510(k) clearance?

TEMPERATURE 132 received FDA 510(k) clearance on 1984-07-17, under 510(k) number K842353.

Who is the listed applicant for TEMPERATURE 132?

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 TEMPERATURE 132?

The FDA product code for TEMPERATURE 132 is HCC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 130K842354EMG MODEL 133K841895GSR, 126, EEG 130-TEMP. 132, EMG 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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