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)

MONITOR, CARDIAC, BEDSIDE

K-Number: K772332 · 1978-02-13

ApplicantTelectronics, Inc.
Decision Date1978-02-13
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, CARDIAC, BEDSIDE is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1978-02-13 under 510(k) number K772332. 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 MONITOR, CARDIAC, BEDSIDE?

MONITOR, CARDIAC, BEDSIDE is a medical device that received FDA 510(k) clearance on 1978-02-13. The listed applicant is Telectronics, Inc.. The 510(k) number is K772332.

When did MONITOR, CARDIAC, BEDSIDE receive FDA 510(k) clearance?

MONITOR, CARDIAC, BEDSIDE received FDA 510(k) clearance on 1978-02-13, under 510(k) number K772332.

Who is the listed applicant for MONITOR, CARDIAC, BEDSIDE?

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

What is the FDA product code for MONITOR, CARDIAC, BEDSIDE?

The FDA product code for MONITOR, CARDIAC, BEDSIDE 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 Telectronics, 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

View all 107 devices →

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.

↑