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FDA 510(k)

540 CAPNOGRAPH

K-Number: K842978 · 1984-08-24

ApplicantSpacelabs, Inc.
Decision Date1984-08-24
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

540 CAPNOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1984-08-24 under 510(k) number K842978. 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 540 CAPNOGRAPH?

540 CAPNOGRAPH is a medical device that received FDA 510(k) clearance on 1984-08-24. The listed applicant is Spacelabs, Inc.. The 510(k) number is K842978.

When did 540 CAPNOGRAPH receive FDA 510(k) clearance?

540 CAPNOGRAPH received FDA 510(k) clearance on 1984-08-24, under 510(k) number K842978.

Who is the listed applicant for 540 CAPNOGRAPH?

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

What is the FDA product code for 540 CAPNOGRAPH?

The FDA product code for 540 CAPNOGRAPH is CCK.

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Other records listing Spacelabs, 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.

K954962SPACELABS MEDICAL MULTIGAS ANALYZERK951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

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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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