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FDA 510(k)

INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000

K-Number: K984444 · 1999-01-11

ApplicantSandhill Scientific, Inc.
Decision Date1999-01-11
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 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 1999-01-11 under 510(k) number K984444. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000?

INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 is a medical device that received FDA 510(k) clearance on 1999-01-11. The listed applicant is Sandhill Scientific, Inc.. The 510(k) number is K984444.

When did INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 receive FDA 510(k) clearance?

INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 received FDA 510(k) clearance on 1999-01-11, under 510(k) number K984444.

Who is the listed applicant for INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000?

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 INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000?

The FDA product code for INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 is FFX.

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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.

K111013ACEMK012232INSIGHT, MODEL S980000K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBEK002427SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026K990441INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300K961056BIOVIEW MODEL S960000

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Related Devices (Code: FFX)

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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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