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FDA 510(k)

MULTINEX MONITOR (MODIFICATION)

K-Number: K883254 · 1988-09-12

ApplicantDatascope Corp.
Decision Date1988-09-12
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MULTINEX MONITOR (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1988-09-12 under 510(k) number K883254. 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 MULTINEX MONITOR (MODIFICATION)?

MULTINEX MONITOR (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1988-09-12. The listed applicant is Datascope Corp.. The 510(k) number is K883254.

When did MULTINEX MONITOR (MODIFICATION) receive FDA 510(k) clearance?

MULTINEX MONITOR (MODIFICATION) received FDA 510(k) clearance on 1988-09-12, under 510(k) number K883254.

Who is the listed applicant for MULTINEX MONITOR (MODIFICATION)?

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

What is the FDA product code for MULTINEX MONITOR (MODIFICATION)?

The FDA product code for MULTINEX MONITOR (MODIFICATION) is CCL.

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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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