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)

CO 2 SMO PLUS

K-Number: K963380 · 1997-01-22

ApplicantNovametrix Medical Systems, Inc.
Decision Date1997-01-22
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CO 2 SMO PLUS 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 1997-01-22 under 510(k) number K963380. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO 2 SMO PLUS?

CO 2 SMO PLUS is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K963380.

When did CO 2 SMO PLUS receive FDA 510(k) clearance?

CO 2 SMO PLUS received FDA 510(k) clearance on 1997-01-22, under 510(k) number K963380.

Who is the listed applicant for CO 2 SMO PLUS?

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 CO 2 SMO PLUS?

The FDA product code for CO 2 SMO PLUS is BZC.

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 101K963327TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610

View all 45 devices →

Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

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.

↑