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)

VASCUMAP MEDICAL AIR PLETHYSMOGRAPH

K-Number: K914200 · 1991-11-07

ApplicantCarolina Medical Electronics
Decision Date1991-11-07
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUMAP MEDICAL AIR PLETHYSMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical Electronics. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K914200. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCUMAP MEDICAL AIR PLETHYSMOGRAPH?

VASCUMAP MEDICAL AIR PLETHYSMOGRAPH is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Carolina Medical Electronics. The 510(k) number is K914200.

When did VASCUMAP MEDICAL AIR PLETHYSMOGRAPH receive FDA 510(k) clearance?

VASCUMAP MEDICAL AIR PLETHYSMOGRAPH received FDA 510(k) clearance on 1991-11-07, under 510(k) number K914200.

Who is the listed applicant for VASCUMAP MEDICAL AIR PLETHYSMOGRAPH?

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

What is the FDA product code for VASCUMAP MEDICAL AIR PLETHYSMOGRAPH?

The FDA product code for VASCUMAP MEDICAL AIR PLETHYSMOGRAPH is DSB.

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 Carolina Medical Electronics 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.

K874684TC2-64B TRANSCRANIAL DOPPLERK874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLERK864624PROBE, UPTAKE, NUCLEARK843891DOPSCAN PLUS DS1060K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUNDK820272CLINIFLOW II, #701, ELECTROMAGN. BLD. SY

View all 11 devices →

Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex 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.

↑