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FDA 510(k)

PH ANALYSIS MODULE

K-Number: K961346 · 1997-01-29

ApplicantSynectics-Dantec
Decision Date1997-01-29
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PH ANALYSIS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1997-01-29 under 510(k) number K961346. 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 PH ANALYSIS MODULE?

PH ANALYSIS MODULE is a medical device that received FDA 510(k) clearance on 1997-01-29. The listed applicant is Synectics-Dantec. The 510(k) number is K961346.

When did PH ANALYSIS MODULE receive FDA 510(k) clearance?

PH ANALYSIS MODULE received FDA 510(k) clearance on 1997-01-29, under 510(k) number K961346.

Who is the listed applicant for PH ANALYSIS MODULE?

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 PH ANALYSIS MODULE?

The FDA product code for PH ANALYSIS MODULE 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.

K925405ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.K924875MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONSK914793MONOCRYSTANT PH/LES CATHETER, MODIFICATIONK924383SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM UROK913817MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATIONK914624PH METER, 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.K950087LOT 440Medical Instruments Corporation Mic AGK955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORInstrumentarium Corp.K945069FLEXILOG 2000Oakfield Instruments, Ltd.

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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