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FDA 510(k)

MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE

K-Number: K030547 · 2003-07-11

ApplicantGuardian Angel Products, Inc.
Decision Date2003-07-11
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Angel Products, Inc.. It received FDA 510(k) clearance on 2003-07-11 under 510(k) number K030547. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE?

MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is Guardian Angel Products, Inc.. The 510(k) number is K030547.

When did MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE receive FDA 510(k) clearance?

MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE received FDA 510(k) clearance on 2003-07-11, under 510(k) number K030547.

Who is the listed applicant for MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE?

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

What is the FDA product code for MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE?

The FDA product code for MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE is DRL.

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 Guardian Angel Products, 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.

K923840NEEDLE-GRABBERK923835THE ELEVENTH FINGERK910687GUARDIAN GEL, SURGEON'S GLOVING CREAMK896985ZAP-GUARD

Related Devices (Code: DRL)

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.

K190437Delta 3300Netech CorporationK182905UniPulseSeaward GroupK110192DEFIBRILLATOR ANALYZER - DA-2006PBc Group International, Inc.K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSFluke BiomedicalK072114IMPULSE 6000D/7000DPFluke BiomedicalK062099PHASE 3, MODEL DT-1Datrend Systems, 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.

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