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FDA 510(k)

HEARTSINE SAMARITAN PAD 350P

K-Number: K123881 · 2013-07-11

ApplicantHeartsine Technologies, Inc.
Decision Date2013-07-11
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSINE SAMARITAN PAD 350P 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 2013-07-11 under 510(k) number K123881. 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 HEARTSINE SAMARITAN PAD 350P?

HEARTSINE SAMARITAN PAD 350P is a medical device that received FDA 510(k) clearance on 2013-07-11. The listed applicant is Heartsine Technologies, Inc.. The 510(k) number is K123881.

When did HEARTSINE SAMARITAN PAD 350P receive FDA 510(k) clearance?

HEARTSINE SAMARITAN PAD 350P received FDA 510(k) clearance on 2013-07-11, under 510(k) number K123881.

Who is the listed applicant for HEARTSINE SAMARITAN PAD 350P?

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 HEARTSINE SAMARITAN PAD 350P?

The FDA product code for HEARTSINE SAMARITAN PAD 350P is MKJ. This falls under the Dental category.

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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.

K052465REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351K042088SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301K041067HEARTSINE SAMARITAN PADK023854SAMARITAN AED, MODEL SAM-01

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.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical SystemsK113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC

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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