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FDA 510(k)

ESOPHAGEAL MANOMETRY ANALYSIS MODULE

K-Number: K961070 · 1996-06-11

ApplicantSynectics Medical, Inc.
Decision Date1996-06-11
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL MANOMETRY ANALYSIS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Synectics Medical, Inc.. It received FDA 510(k) clearance on 1996-06-11 under 510(k) number K961070. 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 ESOPHAGEAL MANOMETRY ANALYSIS MODULE?

ESOPHAGEAL MANOMETRY ANALYSIS MODULE is a medical device that received FDA 510(k) clearance on 1996-06-11. The listed applicant is Synectics Medical, Inc.. The 510(k) number is K961070.

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

ESOPHAGEAL MANOMETRY ANALYSIS MODULE received FDA 510(k) clearance on 1996-06-11, under 510(k) number K961070.

Who is the listed applicant for ESOPHAGEAL MANOMETRY ANALYSIS MODULE?

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

What is the FDA product code for ESOPHAGEAL MANOMETRY ANALYSIS MODULE?

The FDA product code for ESOPHAGEAL MANOMETRY ANALYSIS MODULE is KLA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Synectics Medical, Inc. 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.

K963330URODYNAMIC ANALYSIS MODULEK951442FLOLABK946322POLYGRAM SOFTWAREK942445SYNERGY II

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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