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)

MONITRON MODEL JL-7

K-Number: K820353 · 1982-03-12

ApplicantFlorida Medical Equipment Repair, Inc.
Decision Date1982-03-12
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONITRON MODEL JL-7 is the device name listed in this FDA 510(k) record. The listed applicant is Florida Medical Equipment Repair, Inc.. It received FDA 510(k) clearance on 1982-03-12 under 510(k) number K820353. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITRON MODEL JL-7?

MONITRON MODEL JL-7 is a medical device that received FDA 510(k) clearance on 1982-03-12. The listed applicant is Florida Medical Equipment Repair, Inc.. The 510(k) number is K820353.

When did MONITRON MODEL JL-7 receive FDA 510(k) clearance?

MONITRON MODEL JL-7 received FDA 510(k) clearance on 1982-03-12, under 510(k) number K820353.

Who is the listed applicant for MONITRON MODEL JL-7?

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

What is the FDA product code for MONITRON MODEL JL-7?

The FDA product code for MONITRON MODEL JL-7 is CAP.

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 Florida Medical Equipment Repair, 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.

K813198RESPIRATOR MONITOR

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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.

↑