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FDA 510(k)

AG-820PA FI02 MODULE

K-Number: K896359 · 1990-03-09

ApplicantNihon Kohden America, Inc.
Decision Date1990-03-09
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AG-820PA FI02 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1990-03-09 under 510(k) number K896359. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AG-820PA FI02 MODULE?

AG-820PA FI02 MODULE is a medical device that received FDA 510(k) clearance on 1990-03-09. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K896359.

When did AG-820PA FI02 MODULE receive FDA 510(k) clearance?

AG-820PA FI02 MODULE received FDA 510(k) clearance on 1990-03-09, under 510(k) number K896359.

Who is the listed applicant for AG-820PA FI02 MODULE?

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

What is the FDA product code for AG-820PA FI02 MODULE?

The FDA product code for AG-820PA FI02 MODULE is CCL.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med 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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