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)

HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85

K-Number: K821942 · 1982-08-24

ApplicantHarvey-Bostwick, Inc.
Decision Date1982-08-24
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 is the device name listed in this FDA 510(k) record. The listed applicant is Harvey-Bostwick, Inc.. It received FDA 510(k) clearance on 1982-08-24 under 510(k) number K821942. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85?

HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Harvey-Bostwick, Inc.. The 510(k) number is K821942.

When did HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 receive FDA 510(k) clearance?

HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 received FDA 510(k) clearance on 1982-08-24, under 510(k) number K821942.

Who is the listed applicant for HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85?

The FDA 510(k) record lists Harvey-Bostwick, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85?

The FDA product code for HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 is DRT.

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 Harvey-Bostwick, 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.

K830666APNEA/BRADYCARDIA MONITOR HB 95

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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.

↑