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FDA 510(k)

CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120

K-Number: K896974 · 1990-02-05

ApplicantDaily Medical Products, Inc.
Decision Date1990-02-05
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 is the device name listed in this FDA 510(k) record. The listed applicant is Daily Medical Products, Inc.. It received FDA 510(k) clearance on 1990-02-05 under 510(k) number K896974. 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 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120?

CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 is a medical device that received FDA 510(k) clearance on 1990-02-05. The listed applicant is Daily Medical Products, Inc.. The 510(k) number is K896974.

When did CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 receive FDA 510(k) clearance?

CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 received FDA 510(k) clearance on 1990-02-05, under 510(k) number K896974.

Who is the listed applicant for CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120?

The FDA 510(k) record lists Daily Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120?

The FDA product code for CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 is DWC.

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Other records listing Daily Medical Products, 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.

K914005FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000K905652MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000K905568TOPICAL COOLING PAD, MODEL 7000K896973CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320K896972CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520K896971CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420

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Related Devices (Code: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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