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FDA 510(k)

MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT

K-Number: K902366 · 1990-06-08

ApplicantSynectics-Dantec
Decision Date1990-06-08
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1990-06-08 under 510(k) number K902366. 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 MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT?

MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT is a medical device that received FDA 510(k) clearance on 1990-06-08. The listed applicant is Synectics-Dantec. The 510(k) number is K902366.

When did MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT receive FDA 510(k) clearance?

MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT received FDA 510(k) clearance on 1990-06-08, under 510(k) number K902366.

Who is the listed applicant for MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT?

The FDA 510(k) record lists Synectics-Dantec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT?

The FDA product code for MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT is FFT.

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Other records listing Synectics-Dantec 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.

K961346PH ANALYSIS MODULEK925405ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.K924875MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONSK914793MONOCRYSTANT PH/LES CATHETER, MODIFICATIONK924383SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM UROK913817MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION

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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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