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FDA 510(k)

SMARTO

K-Number: K101563 · 2010-12-17

ApplicantJeil Medical Corporation
Decision Date2010-12-17
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTO is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2010-12-17 under 510(k) number K101563. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTO?

SMARTO is a medical device that received FDA 510(k) clearance on 2010-12-17. The listed applicant is Jeil Medical Corporation. The 510(k) number is K101563.

When did SMARTO receive FDA 510(k) clearance?

SMARTO received FDA 510(k) clearance on 2010-12-17, under 510(k) number K101563.

Who is the listed applicant for SMARTO?

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

What is the FDA product code for SMARTO?

The FDA product code for SMARTO is KIJ.

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Other records listing Jeil Medical Corporation as applicant

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Related Devices (Code: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, Inc.K951450SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERYStrenumed, 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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