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)

MODEL #918 MULTI-PADS

K-Number: K883375 · 1988-08-30

ApplicantCardiotronics, Inc.
Decision Date1988-08-30
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL #918 MULTI-PADS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K883375. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL #918 MULTI-PADS?

MODEL #918 MULTI-PADS is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K883375.

When did MODEL #918 MULTI-PADS receive FDA 510(k) clearance?

MODEL #918 MULTI-PADS received FDA 510(k) clearance on 1988-08-30, under 510(k) number K883375.

Who is the listed applicant for MODEL #918 MULTI-PADS?

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

What is the FDA product code for MODEL #918 MULTI-PADS?

The FDA product code for MODEL #918 MULTI-PADS is DRO.

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 Cardiotronics, 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.

K932903EKG VESTK922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODEK923297MODEL #340 STEALTH-TRODE+LSK922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILEK922172MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)K922173MODEL # 830 ST ADULT STIMULATION PADS (STERILE)

View all 27 devices →

Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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.

↑