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FDA 510(k)

PROACT CLA-1500 SYSTEM

K-Number: K915061 · 1992-01-31

ApplicantClinical Systems, Inc.
Decision Date1992-01-31
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROACT CLA-1500 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Systems, Inc.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K915061. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROACT CLA-1500 SYSTEM?

PROACT CLA-1500 SYSTEM is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Clinical Systems, Inc.. The 510(k) number is K915061.

When did PROACT CLA-1500 SYSTEM receive FDA 510(k) clearance?

PROACT CLA-1500 SYSTEM received FDA 510(k) clearance on 1992-01-31, under 510(k) number K915061.

Who is the listed applicant for PROACT CLA-1500 SYSTEM?

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

What is the FDA product code for PROACT CLA-1500 SYSTEM?

The FDA product code for PROACT CLA-1500 SYSTEM is FNM.

Related Clinical Trials

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.

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Other records listing Clinical Systems, 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.

K921050ULTRAFLO RATESAVER PLUS INFUSION PUMPK901458NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP

Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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