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)

HEART PROTECTOR (VER 1996)

K-Number: K965158 · 1997-12-09

ApplicantN.P.N.T., Inc.
Decision Date1997-12-09
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART PROTECTOR (VER 1996) is the device name listed in this FDA 510(k) record. The listed applicant is N.P.N.T., Inc.. It received FDA 510(k) clearance on 1997-12-09 under 510(k) number K965158. 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 HEART PROTECTOR (VER 1996)?

HEART PROTECTOR (VER 1996) is a medical device that received FDA 510(k) clearance on 1997-12-09. The listed applicant is N.P.N.T., Inc.. The 510(k) number is K965158.

When did HEART PROTECTOR (VER 1996) receive FDA 510(k) clearance?

HEART PROTECTOR (VER 1996) received FDA 510(k) clearance on 1997-12-09, under 510(k) number K965158.

Who is the listed applicant for HEART PROTECTOR (VER 1996)?

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

What is the FDA product code for HEART PROTECTOR (VER 1996)?

The FDA product code for HEART PROTECTOR (VER 1996) 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

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.

↑