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FDA 510(k)

FIRST MEDIC MODE 610

K-Number: K883584 · 1988-10-06

ApplicantFirst Medical Devices Corp.
Decision Date1988-10-06
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIRST MEDIC MODE 610 is the device name listed in this FDA 510(k) record. The listed applicant is First Medical Devices Corp.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K883584. 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 FIRST MEDIC MODE 610?

FIRST MEDIC MODE 610 is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is First Medical Devices Corp.. The 510(k) number is K883584.

When did FIRST MEDIC MODE 610 receive FDA 510(k) clearance?

FIRST MEDIC MODE 610 received FDA 510(k) clearance on 1988-10-06, under 510(k) number K883584.

Who is the listed applicant for FIRST MEDIC MODE 610?

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

What is the FDA product code for FIRST MEDIC MODE 610?

The FDA product code for FIRST MEDIC MODE 610 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 First Medical Devices 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.

K903657MODEL 610 MODIFIEDK895185FIRST MEDIC MODEL 610PK880780HEARTSTART 2000 DEFIBRILLATOR TESTER, ECGK871136HEARTSTART 2000, MANUAL DEFIBRILLATORK871135HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULEK860676HEARTSTART 2000

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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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