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FDA 510(k)

SAMARITAN AED, MODEL SAM-01

K-Number: K023854 · 2003-02-14

ApplicantHeartsine Technologies, Inc.
Decision Date2003-02-14
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAMARITAN AED, MODEL SAM-01 is the device name listed in this FDA 510(k) record. The listed applicant is Heartsine Technologies, Inc.. It received FDA 510(k) clearance on 2003-02-14 under 510(k) number K023854. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMARITAN AED, MODEL SAM-01?

SAMARITAN AED, MODEL SAM-01 is a medical device that received FDA 510(k) clearance on 2003-02-14. The listed applicant is Heartsine Technologies, Inc.. The 510(k) number is K023854.

When did SAMARITAN AED, MODEL SAM-01 receive FDA 510(k) clearance?

SAMARITAN AED, MODEL SAM-01 received FDA 510(k) clearance on 2003-02-14, under 510(k) number K023854.

Who is the listed applicant for SAMARITAN AED, MODEL SAM-01?

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

What is the FDA product code for SAMARITAN AED, MODEL SAM-01?

The FDA product code for SAMARITAN AED, MODEL SAM-01 is MKJ. This falls under the Dental 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.

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Other records listing Heartsine Technologies, 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.

K123881HEARTSINE SAMARITAN PAD 350PK052465REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351K042088SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301K041067HEARTSINE SAMARITAN PAD

Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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