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FDA 510(k)

MON-A-THERM MYOCARDIAL TEMP. SENSOR

K-Number: K823435 · 1982-12-30

ApplicantBurditt & Calkins-Siemens-Elema
Decision Date1982-12-30
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MON-A-THERM MYOCARDIAL TEMP. SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Burditt & Calkins-Siemens-Elema. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823435. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MON-A-THERM MYOCARDIAL TEMP. SENSOR?

MON-A-THERM MYOCARDIAL TEMP. SENSOR is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Burditt & Calkins-Siemens-Elema. The 510(k) number is K823435.

When did MON-A-THERM MYOCARDIAL TEMP. SENSOR receive FDA 510(k) clearance?

MON-A-THERM MYOCARDIAL TEMP. SENSOR received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823435.

Who is the listed applicant for MON-A-THERM MYOCARDIAL TEMP. SENSOR?

The FDA 510(k) record lists Burditt & Calkins-Siemens-Elema as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MON-A-THERM MYOCARDIAL TEMP. SENSOR?

The FDA product code for MON-A-THERM MYOCARDIAL TEMP. SENSOR is KRB.

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Other records listing Burditt & Calkins-Siemens-Elema 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.

K833519PULSE GENERATOR MODEL 688K833155RAYDEN MEDICAL MINI PULSE VOLUME RECORDK830344SIEMENS-ELMA PULSE GENERATOR #718K823591AMEDA HAND BREAST PUMPK822239COAXIAL BIPOLAR PACING ELECTRODEK821712INFORMED REMOTE FIELD UNIT MODEL IFM1000

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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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