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FDA 510(k)

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

K-Number: K102147 · 2010-11-19

ApplicantCardioquip Llp
Decision Date2010-11-19
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cardioquip Llp. It received FDA 510(k) clearance on 2010-11-19 under 510(k) number K102147. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000?

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Cardioquip Llp. The 510(k) number is K102147.

When did CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 receive FDA 510(k) clearance?

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 received FDA 510(k) clearance on 2010-11-19, under 510(k) number K102147.

Who is the listed applicant for CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000?

The FDA 510(k) record lists Cardioquip Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000?

The FDA product code for CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 is DWC.

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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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