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FDA 510(k)

CRITERION 60 OR PM 60

K-Number: K000959 · 2000-06-22

ApplicantCaradyne, Ltd.
Decision Date2000-06-22
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRITERION 60 OR PM 60 is the device name listed in this FDA 510(k) record. The listed applicant is Caradyne, Ltd.. It received FDA 510(k) clearance on 2000-06-22 under 510(k) number K000959. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITERION 60 OR PM 60?

CRITERION 60 OR PM 60 is a medical device that received FDA 510(k) clearance on 2000-06-22. The listed applicant is Caradyne, Ltd.. The 510(k) number is K000959.

When did CRITERION 60 OR PM 60 receive FDA 510(k) clearance?

CRITERION 60 OR PM 60 received FDA 510(k) clearance on 2000-06-22, under 510(k) number K000959.

Who is the listed applicant for CRITERION 60 OR PM 60?

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

What is the FDA product code for CRITERION 60 OR PM 60?

The FDA product code for CRITERION 60 OR PM 60 is CAP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Caradyne, Ltd. 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.

K040862GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEMK023565OXICHECKK992101CRITERION 40 OR PM 40K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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