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)

NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER

K-Number: K850487 · 1985-03-29

ApplicantNovametrix Medical Systems, Inc.
Decision Date1985-03-29
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER 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 1985-03-29 under 510(k) number K850487. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER?

NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER is a medical device that received FDA 510(k) clearance on 1985-03-29. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K850487.

When did NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER receive FDA 510(k) clearance?

NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER received FDA 510(k) clearance on 1985-03-29, under 510(k) number K850487.

Who is the listed applicant for NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER?

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 NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER?

The FDA product code for NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER is DSF.

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: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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.

↑