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FDA 510(k)

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4

K-Number: K963698 · 1997-03-20

ApplicantInternational Biophysics Corp.
Decision Date1997-03-20
Product CodeDTY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corp.. It received FDA 510(k) clearance on 1997-03-20 under 510(k) number K963698. The device is classified under product code DTY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4?

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 is a medical device that received FDA 510(k) clearance on 1997-03-20. The listed applicant is International Biophysics Corp.. The 510(k) number is K963698.

When did CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 receive FDA 510(k) clearance?

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 received FDA 510(k) clearance on 1997-03-20, under 510(k) number K963698.

Who is the listed applicant for CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4?

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

What is the FDA product code for CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4?

The FDA product code for CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 is DTY.

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Other records listing International Biophysics Corp. as applicant

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Related Devices (Code: DTY)

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.

K093650BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMMedtronic, Inc.K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMMedtronic Bio-Medicus, Inc.K902654CDI (TM) SYSTEM 100 MONITORING SYSTEM3M Health Care, Ltd.K900860PERFUSION MONITORCardio Metrics, Inc.K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMCardiovascular Devices, Inc.K840749GAST STAT MONITORING SYSTEMCardiovascular Devices, Inc.

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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