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FDA 510(k)

SANDMILL RMS

K-Number: K834512 · 1984-02-21

ApplicantSandhill Scientific, Inc.
Decision Date1984-02-21
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SANDMILL RMS 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 1984-02-21 under 510(k) number K834512. The device is classified under product code FFT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDMILL RMS?

SANDMILL RMS is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Sandhill Scientific, Inc.. The 510(k) number is K834512.

When did SANDMILL RMS receive FDA 510(k) clearance?

SANDMILL RMS received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834512.

Who is the listed applicant for SANDMILL RMS?

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 SANDMILL RMS?

The FDA product code for SANDMILL RMS is FFT.

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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 S981300K984444INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000

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Related Devices (Code: FFT)

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.

K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESGiven Imaging , Ltd.K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBESandhill Scientific, Inc.K002028BRAVO PH MONITORING SYSTEMEndonetics, Inc.K961346PH ANALYSIS MODULESynectics-DantecK950087LOT 440Medical Instruments Corporation Mic AGK955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORInstrumentarium Corp.

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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