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FDA 510(k)

ZINETICS(R) EMC

K-Number: K884527 · 1989-02-28

ApplicantZinetics Medical, Inc.
Decision Date1989-02-28
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ZINETICS(R) EMC is the device name listed in this FDA 510(k) record. The listed applicant is Zinetics Medical, Inc.. It received FDA 510(k) clearance on 1989-02-28 under 510(k) number K884527. 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 ZINETICS(R) EMC?

ZINETICS(R) EMC is a medical device that received FDA 510(k) clearance on 1989-02-28. The listed applicant is Zinetics Medical, Inc.. The 510(k) number is K884527.

When did ZINETICS(R) EMC receive FDA 510(k) clearance?

ZINETICS(R) EMC received FDA 510(k) clearance on 1989-02-28, under 510(k) number K884527.

Who is the listed applicant for ZINETICS(R) EMC?

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

What is the FDA product code for ZINETICS(R) EMC?

The FDA product code for ZINETICS(R) EMC 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.

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Other records listing Zinetics 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.

K921682ZINETICS AMCK910694ZINETICS INTERNAL REFERENCE PROBEK883319HILL NASOGASTRIC TUBE

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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