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FDA 510(k)

AIRWAY TEMPERATURE SENSOR

K-Number: K821505 · 1982-12-09

ApplicantMon-A-Therm, Inc.
Decision Date1982-12-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AIRWAY TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Mon-A-Therm, Inc.. It received FDA 510(k) clearance on 1982-12-09 under 510(k) number K821505. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRWAY TEMPERATURE SENSOR?

AIRWAY TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1982-12-09. The listed applicant is Mon-A-Therm, Inc.. The 510(k) number is K821505.

When did AIRWAY TEMPERATURE SENSOR receive FDA 510(k) clearance?

AIRWAY TEMPERATURE SENSOR received FDA 510(k) clearance on 1982-12-09, under 510(k) number K821505.

Who is the listed applicant for AIRWAY TEMPERATURE SENSOR?

The FDA 510(k) record lists Mon-A-Therm, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRWAY TEMPERATURE SENSOR?

The FDA product code for AIRWAY TEMPERATURE SENSOR is GEI.

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Other records listing Mon-A-Therm, 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.

K885187MODEL 1000 ELECTRONIC CLINICAL THERMOMETERK874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORK874522MODIFIED MYOCARDIAL TEMPERATURE SENSORK875234MON-A-THERM'S SKIN TEMPERATURE SENSORK874523MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSORK874524MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR

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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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