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)

PDT CARRYALL TRANSMITTER, VARIOUS MODELS

K-Number: K912379 · 1991-06-17

ApplicantCardiac Pacemakers, Inc.
Decision Date1991-06-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PDT CARRYALL TRANSMITTER, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K912379. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDT CARRYALL TRANSMITTER, VARIOUS MODELS?

PDT CARRYALL TRANSMITTER, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K912379.

When did PDT CARRYALL TRANSMITTER, VARIOUS MODELS receive FDA 510(k) clearance?

PDT CARRYALL TRANSMITTER, VARIOUS MODELS received FDA 510(k) clearance on 1991-06-17, under 510(k) number K912379.

Who is the listed applicant for PDT CARRYALL TRANSMITTER, VARIOUS MODELS?

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

What is the FDA product code for PDT CARRYALL TRANSMITTER, VARIOUS MODELS?

The FDA product code for PDT CARRYALL TRANSMITTER, VARIOUS MODELS is DXH. This falls under the Hematology category.

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 Cardiac Pacemakers, 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.

K093969ACUITY BREAK-AWAY GUIDE CATHETERK080154ACUITY UNIVERSAL CUTTERK934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERK920601ASTRA T2, ASTRA T4, ASTRA T6K905674LEAD STYLETK900498MODIFIED BETATRON IV INSULIN INFUSION SYSTEM

View all 76 devices →

Related Devices (Code: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, 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.

↑