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FDA 510(k)

NORMOCAP CR-102, RECORDER UNIT

K-Number: K802762 · 1980-11-26

ApplicantInstrumentarium-Datex
Decision Date1980-11-26
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NORMOCAP CR-102, RECORDER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium-Datex. It received FDA 510(k) clearance on 1980-11-26 under 510(k) number K802762. 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 NORMOCAP CR-102, RECORDER UNIT?

NORMOCAP CR-102, RECORDER UNIT is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is Instrumentarium-Datex. The 510(k) number is K802762.

When did NORMOCAP CR-102, RECORDER UNIT receive FDA 510(k) clearance?

NORMOCAP CR-102, RECORDER UNIT received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802762.

Who is the listed applicant for NORMOCAP CR-102, RECORDER UNIT?

The FDA 510(k) record lists Instrumentarium-Datex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMOCAP CR-102, RECORDER UNIT?

The FDA product code for NORMOCAP CR-102, RECORDER UNIT is CCL.

Related Clinical Trials

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Other records listing Instrumentarium-Datex 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.

K801083NORMCAP CD-102, CARBON DIOXIDE ANALYZER

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

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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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