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FDA 510(k)

BIO-CAL 370 HEATER/COOLER

K-Number: K894980 · 1989-11-02

ApplicantBio Medicus, Inc.
Decision Date1989-11-02
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-CAL 370 HEATER/COOLER is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medicus, Inc.. It received FDA 510(k) clearance on 1989-11-02 under 510(k) number K894980. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CAL 370 HEATER/COOLER?

BIO-CAL 370 HEATER/COOLER is a medical device that received FDA 510(k) clearance on 1989-11-02. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K894980.

When did BIO-CAL 370 HEATER/COOLER receive FDA 510(k) clearance?

BIO-CAL 370 HEATER/COOLER received FDA 510(k) clearance on 1989-11-02, under 510(k) number K894980.

Who is the listed applicant for BIO-CAL 370 HEATER/COOLER?

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

What is the FDA product code for BIO-CAL 370 HEATER/COOLER?

The FDA product code for BIO-CAL 370 HEATER/COOLER is DWJ.

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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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