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FDA 510(k)

DIGITRAPPER MARK III

K-Number: K913387 · 1991-12-27

ApplicantSynectics-Dantec
Decision Date1991-12-27
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIGITRAPPER MARK III is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K913387. 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 DIGITRAPPER MARK III?

DIGITRAPPER MARK III is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Synectics-Dantec. The 510(k) number is K913387.

When did DIGITRAPPER MARK III receive FDA 510(k) clearance?

DIGITRAPPER MARK III received FDA 510(k) clearance on 1991-12-27, under 510(k) number K913387.

Who is the listed applicant for DIGITRAPPER MARK III?

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 DIGITRAPPER MARK III?

The FDA product code for DIGITRAPPER MARK III 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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