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)

RATE PROGRAMMER MODEL 520

K-Number: K780175 · 1978-04-21

ApplicantIntermedics, Inc.
Decision Date1978-04-21
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RATE PROGRAMMER MODEL 520 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1978-04-21 under 510(k) number K780175. The device is classified under product code KRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RATE PROGRAMMER MODEL 520?

RATE PROGRAMMER MODEL 520 is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is Intermedics, Inc.. The 510(k) number is K780175.

When did RATE PROGRAMMER MODEL 520 receive FDA 510(k) clearance?

RATE PROGRAMMER MODEL 520 received FDA 510(k) clearance on 1978-04-21, under 510(k) number K780175.

Who is the listed applicant for RATE PROGRAMMER MODEL 520?

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

What is the FDA product code for RATE PROGRAMMER MODEL 520?

The FDA product code for RATE PROGRAMMER MODEL 520 is KRG.

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 Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 devices →

Related Devices (Code: KRG)

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.

K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMERTeletronics, Inc.K880738MODEL 2331T PATIENT PROGRAMMERMedtronic VascularK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.K871986MODEL 5600B PROGRAMMER, PACEMAKERTelectronics, Inc.

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.

↑