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)

NARCOTRACE 80

K-Number: K830338 · 1983-12-22

ApplicantNarco Scientific
Decision Date1983-12-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NARCOTRACE 80 is the device name listed in this FDA 510(k) record. The listed applicant is Narco Scientific. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K830338. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NARCOTRACE 80?

NARCOTRACE 80 is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Narco Scientific. The 510(k) number is K830338.

When did NARCOTRACE 80 receive FDA 510(k) clearance?

NARCOTRACE 80 received FDA 510(k) clearance on 1983-12-22, under 510(k) number K830338.

Who is the listed applicant for NARCOTRACE 80?

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

What is the FDA product code for NARCOTRACE 80?

The FDA product code for NARCOTRACE 80 is DXN.

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 Narco Scientific 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.

K831429AS 191 ECG TELEMETRY MODULEK831428AS 1740 INTERFACE MODULEK822835PZ-800 VOLUME VENTILATORK831430AIR SHIELDS AS-100 MONIORING SYS-AS105K831460AS 30/TCP MODULEK830123DISP. YANKAVER SURG. SUCTION INSTRUMENT

View all 30 devices →

Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, 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.

↑