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FDA 510(k)

FIRSTSAVE BIPHASIC MODEL #9200 AND 9210

K-Number: K010214 · 2001-02-22

ApplicantSurvivalink Corp.
Decision Date2001-02-22
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 is the device name listed in this FDA 510(k) record. The listed applicant is Survivalink Corp.. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K010214. 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 FIRSTSAVE BIPHASIC MODEL #9200 AND 9210?

FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Survivalink Corp.. The 510(k) number is K010214.

When did FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 receive FDA 510(k) clearance?

FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 received FDA 510(k) clearance on 2001-02-22, under 510(k) number K010214.

Who is the listed applicant for FIRSTSAVE BIPHASIC MODEL #9200 AND 9210?

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

What is the FDA product code for FIRSTSAVE BIPHASIC MODEL #9200 AND 9210?

The FDA product code for FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 is MKJ. This falls under the Dental category.

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Other records listing Survivalink Corp. 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.

K011901FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200K993072SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)K982264FIRSTSAVE BIPHASIC MODELS 9200 AND 9210K970481V2K971149SVL-9130 DEFIBRILLATION ELECTRODEK940445VIVALINK AED DEFIBRILLATOR

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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

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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