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FDA 510(k)

ACEM

K-Number: K111013 · 2011-12-19

ApplicantSandhill Scientific, Inc.
Decision Date2011-12-19
Product CodeFFZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACEM is the device name listed in this FDA 510(k) record. The listed applicant is Sandhill Scientific, Inc.. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K111013. The device is classified under product code FFZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACEM?

ACEM is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Sandhill Scientific, Inc.. The 510(k) number is K111013.

When did ACEM receive FDA 510(k) clearance?

ACEM received FDA 510(k) clearance on 2011-12-19, under 510(k) number K111013.

Who is the listed applicant for ACEM?

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

What is the FDA product code for ACEM?

The FDA product code for ACEM is FFZ.

Related PubMed Literature

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.

PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open ()PMID: 41839575A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.International journal of spine surgery ()PMID: 40886969Is Tattooing an Injection? Evaluating the Mechanics of Ink Placement.Acta biomaterialia ()PMID: 37209414Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.Journal of cardiovascular electrophysiology ()

Other records listing Sandhill Scientific, 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.

K012232INSIGHT, MODEL S980000K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBEK002427SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026K990441INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300K984444INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000K961056BIOVIEW MODEL S960000

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Related Devices (Code: FFZ)

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.

K822254ELECTRIC CORD FOR ENDOSCOPEKelleher Corp.K782046C-CORDConcept, 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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