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FDA 510(k)

MULTICAP MULTIGAS CAPNOMETER PB252

K-Number: K853396 · 1985-08-16

ApplicantInstrumentarium Corp.
Decision Date1985-08-16
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MULTICAP MULTIGAS CAPNOMETER PB252 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1985-08-16 under 510(k) number K853396. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTICAP MULTIGAS CAPNOMETER PB252?

MULTICAP MULTIGAS CAPNOMETER PB252 is a medical device that received FDA 510(k) clearance on 1985-08-16. The listed applicant is Instrumentarium Corp.. The 510(k) number is K853396.

When did MULTICAP MULTIGAS CAPNOMETER PB252 receive FDA 510(k) clearance?

MULTICAP MULTIGAS CAPNOMETER PB252 received FDA 510(k) clearance on 1985-08-16, under 510(k) number K853396.

Who is the listed applicant for MULTICAP MULTIGAS CAPNOMETER PB252?

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

What is the FDA product code for MULTICAP MULTIGAS CAPNOMETER PB252?

The FDA product code for MULTICAP MULTIGAS CAPNOMETER PB252 is CCK.

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Other records listing Instrumentarium Corp. as applicant

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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