Decision Date1995-02-07
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
QC CAP is the device name listed in this FDA 510(k) record. The listed applicant is Medionics International, Inc.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K945567. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QC CAP?
QC CAP is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Medionics International, Inc.. The 510(k) number is K945567.
When did QC CAP receive FDA 510(k) clearance?
QC CAP received FDA 510(k) clearance on 1995-02-07, under 510(k) number K945567.
Who is the listed applicant for QC CAP?
The FDA 510(k) record lists Medionics International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QC CAP?
The FDA product code for QC CAP is KDJ.
Other records listing Medionics International, 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.
Related Devices (Code: KDJ)
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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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.