Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610

K-Number: K963327 · 1996-11-20

ApplicantNovametrix Medical Systems, Inc.
Decision Date1996-11-20
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 is the device name listed in this FDA 510(k) record. The listed applicant is Novametrix Medical Systems, Inc.. It received FDA 510(k) clearance on 1996-11-20 under 510(k) number K963327. 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 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610?

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 is a medical device that received FDA 510(k) clearance on 1996-11-20. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K963327.

When did TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 receive FDA 510(k) clearance?

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 received FDA 510(k) clearance on 1996-11-20, under 510(k) number K963327.

Who is the listed applicant for TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610?

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

What is the FDA product code for TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610?

The FDA product code for TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 is CCK.

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 Novametrix Medical Systems, 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.

K010451NOVAMETRIX MARQUETTE COMPATIBLE SENSORSK000794MODIFICATION TO MARSPO2, MODEL 2001K993979MARSPO2, MODEL 2001K982499COSMO PLUS WITH NICO, MODEL 8200K964360VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101K963380CO 2 SMO PLUS

View all 45 devices →

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.

↑