Decision Date1988-05-19
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
IQK-200 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Repackers Co.. It received FDA 510(k) clearance on 1988-05-19 under 510(k) number K881313. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IQK-200?
IQK-200 is a medical device that received FDA 510(k) clearance on 1988-05-19. The listed applicant is Medical Repackers Co.. The 510(k) number is K881313.
When did IQK-200 receive FDA 510(k) clearance?
IQK-200 received FDA 510(k) clearance on 1988-05-19, under 510(k) number K881313.
Who is the listed applicant for IQK-200?
The FDA 510(k) record lists Medical Repackers Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IQK-200?
The FDA product code for IQK-200 is BTR.
Other records listing Medical Repackers Co. 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: BTR)
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.