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FDA 510(k)

PC POLYGRAF

K-Number: K872712 · 1988-03-18

ApplicantSynectics-Dantec
Decision Date1988-03-18
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PC POLYGRAF is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1988-03-18 under 510(k) number K872712. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PC POLYGRAF?

PC POLYGRAF is a medical device that received FDA 510(k) clearance on 1988-03-18. The listed applicant is Synectics-Dantec. The 510(k) number is K872712.

When did PC POLYGRAF receive FDA 510(k) clearance?

PC POLYGRAF received FDA 510(k) clearance on 1988-03-18, under 510(k) number K872712.

Who is the listed applicant for PC POLYGRAF?

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 PC POLYGRAF?

The FDA product code for PC POLYGRAF is KLA.

Related Clinical Trials

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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: KLA)

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.

K242666Fecobionics Anorectal SystemGi Bionics, LLCK242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd SpaK120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC

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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