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FDA 510(k)

SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E

K-Number: K850361 · 1985-05-01

ApplicantSynectics-Dantec
Decision Date1985-05-01
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K850361. 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 SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E?

SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Synectics-Dantec. The 510(k) number is K850361.

When did SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E receive FDA 510(k) clearance?

SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E received FDA 510(k) clearance on 1985-05-01, under 510(k) number K850361.

Who is the listed applicant for SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E?

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 SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E?

The FDA product code for SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E 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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