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)

VASCULAR RECORDER #301

K-Number: K832369 · 1984-03-12

Decision Date1984-03-12
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAR RECORDER #301 is the device name listed in this FDA 510(k) record. The listed applicant is Imex Medical Systems, Inc.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K832369. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR RECORDER #301?

VASCULAR RECORDER #301 is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K832369.

When did VASCULAR RECORDER #301 receive FDA 510(k) clearance?

VASCULAR RECORDER #301 received FDA 510(k) clearance on 1984-03-12, under 510(k) number K832369.

Who is the listed applicant for VASCULAR RECORDER #301?

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

What is the FDA product code for VASCULAR RECORDER #301?

The FDA product code for VASCULAR RECORDER #301 is JOP.

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.

Other records listing Imex 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.

View all 19 devices →

Related Devices (Code: JOP)

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.

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.

↑