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FDA 510(k)

MODIFIED MYOCARDIAL TEMPERATURE SENSOR

K-Number: K874522 · 1988-01-29

ApplicantMon-A-Therm, Inc.
Decision Date1988-01-29
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED MYOCARDIAL 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 1988-01-29 under 510(k) number K874522. 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 MODIFIED MYOCARDIAL TEMPERATURE SENSOR?

MODIFIED MYOCARDIAL TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1988-01-29. The listed applicant is Mon-A-Therm, Inc.. The 510(k) number is K874522.

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

MODIFIED MYOCARDIAL TEMPERATURE SENSOR received FDA 510(k) clearance on 1988-01-29, under 510(k) number K874522.

Who is the listed applicant for MODIFIED MYOCARDIAL 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 MODIFIED MYOCARDIAL TEMPERATURE SENSOR?

The FDA product code for MODIFIED MYOCARDIAL TEMPERATURE SENSOR is KRB.

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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 SENSORK875234MON-A-THERM'S SKIN TEMPERATURE SENSORK874524MODIFIED SUBCUTANEOUS TEMPERATURE SENSORK874523MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSORK874521MODIFIED THERMAL WELL TEMPERATURE SENSOR

View all 17 devices →

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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