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FDA 510(k)

CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620

K-Number: K896393 · 1990-02-02

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

Device Summary

CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 is the device name listed in this FDA 510(k) record. The listed applicant is Daily Medical, Inc.. It received FDA 510(k) clearance on 1990-02-02 under 510(k) number K896393. 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 JACKED, 16 CM, MODEL CJ-620?

CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 is a medical device that received FDA 510(k) clearance on 1990-02-02. The listed applicant is Daily Medical, Inc.. The 510(k) number is K896393.

When did CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 receive FDA 510(k) clearance?

CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 received FDA 510(k) clearance on 1990-02-02, under 510(k) number K896393.

Who is the listed applicant for CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620?

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

What is the FDA product code for CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620?

The FDA product code for CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 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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