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)

BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS

K-Number: K828565 · 1983-01-03

ApplicantMedical Electronics Corp.
Decision Date1983-01-03
Product Code
DecisionSubstantially Equivalent

Device Summary

BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronics Corp.. It received FDA 510(k) clearance on 1983-01-03 under 510(k) number K828565. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS?

BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS is a medical device that received FDA 510(k) clearance on 1983-01-03. The listed applicant is Medical Electronics Corp.. The 510(k) number is K828565.

When did BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS receive FDA 510(k) clearance?

BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS received FDA 510(k) clearance on 1983-01-03, under 510(k) number K828565.

Who is the listed applicant for BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS?

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

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 Medical Electronics Corp. 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.

K831577TRACHEA/CUFF INFLATOR W/PRESSURE #583

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.

↑