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)

PORTABLE, BATTERY OPERATED DEFIBRILLATOR

K-Number: K810237 · 1981-02-19

ApplicantHoneywell, Inc.
Decision Date1981-02-19
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTABLE, BATTERY OPERATED DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1981-02-19 under 510(k) number K810237. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE, BATTERY OPERATED DEFIBRILLATOR?

PORTABLE, BATTERY OPERATED DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1981-02-19. The listed applicant is Honeywell, Inc.. The 510(k) number is K810237.

When did PORTABLE, BATTERY OPERATED DEFIBRILLATOR receive FDA 510(k) clearance?

PORTABLE, BATTERY OPERATED DEFIBRILLATOR received FDA 510(k) clearance on 1981-02-19, under 510(k) number K810237.

Who is the listed applicant for PORTABLE, BATTERY OPERATED DEFIBRILLATOR?

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

What is the FDA product code for PORTABLE, BATTERY OPERATED DEFIBRILLATOR?

The FDA product code for PORTABLE, BATTERY OPERATED DEFIBRILLATOR is LDD.

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 Honeywell, 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.

K902230COLORADO COLOR IMAGING RECORDERK863100CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECORK853501HONEYWELL ELECTRONIC VENTILATOR EV-AK855125PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEMK851888APM DISPOS. BLOOD PRESSURE TRANSDUCERK851496ECG MONITOR MODEL RM102

View all 69 devices →

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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.

↑