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FDA 510(k)

MODEL 700 GASTROREFLUX MONITOR/AMALYZER

K-Number: K822815 · 1982-10-22

ApplicantDel Mar Avionics
Decision Date1982-10-22
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL 700 GASTROREFLUX MONITOR/AMALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1982-10-22 under 510(k) number K822815. 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 MODEL 700 GASTROREFLUX MONITOR/AMALYZER?

MODEL 700 GASTROREFLUX MONITOR/AMALYZER is a medical device that received FDA 510(k) clearance on 1982-10-22. The listed applicant is Del Mar Avionics. The 510(k) number is K822815.

When did MODEL 700 GASTROREFLUX MONITOR/AMALYZER receive FDA 510(k) clearance?

MODEL 700 GASTROREFLUX MONITOR/AMALYZER received FDA 510(k) clearance on 1982-10-22, under 510(k) number K822815.

Who is the listed applicant for MODEL 700 GASTROREFLUX MONITOR/AMALYZER?

The FDA 510(k) record lists Del Mar Avionics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 700 GASTROREFLUX MONITOR/AMALYZER?

The FDA product code for MODEL 700 GASTROREFLUX MONITOR/AMALYZER is FFT.

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Other records listing Del Mar Avionics 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.

K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K942653HOLTER SSR DIGICORDER(TM)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

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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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