Decision Date1987-01-20
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
I/A/KPE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K864726. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the I/A/KPE TIP?
I/A/KPE TIP is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Ipax, Inc.. The 510(k) number is K864726.
When did I/A/KPE TIP receive FDA 510(k) clearance?
I/A/KPE TIP received FDA 510(k) clearance on 1987-01-20, under 510(k) number K864726.
Who is the listed applicant for I/A/KPE TIP?
The FDA 510(k) record lists Ipax, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for I/A/KPE TIP?
The FDA product code for I/A/KPE TIP is HQC.
Other records listing Ipax, 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.
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Related Devices (Code: HQC)
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
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