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FDA 510(k)

CARDIO-SYSTEMS PRO-OP

K-Number: K953196 · 1995-11-08

ApplicantCh Administration, Inc.
Decision Date1995-11-08
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CARDIO-SYSTEMS PRO-OP is the device name listed in this FDA 510(k) record. The listed applicant is Ch Administration, Inc.. It received FDA 510(k) clearance on 1995-11-08 under 510(k) number K953196. 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 CARDIO-SYSTEMS PRO-OP?

CARDIO-SYSTEMS PRO-OP is a medical device that received FDA 510(k) clearance on 1995-11-08. The listed applicant is Ch Administration, Inc.. The 510(k) number is K953196.

When did CARDIO-SYSTEMS PRO-OP receive FDA 510(k) clearance?

CARDIO-SYSTEMS PRO-OP received FDA 510(k) clearance on 1995-11-08, under 510(k) number K953196.

Who is the listed applicant for CARDIO-SYSTEMS PRO-OP?

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

What is the FDA product code for CARDIO-SYSTEMS PRO-OP?

The FDA product code for CARDIO-SYSTEMS PRO-OP is FNM.

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Other records listing Ch Administration, 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.

K926403PRO-2000 LOW AIR LOSS THERAPY BEDK926402COMFORT CARE LOW AIR LOSS THERAPY BED

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

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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