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FDA 510(k)

BI-PHASIC INFILTRATOR

K-Number: K012044 · 2001-08-28

ApplicantReliance Medical Corp.
Decision Date2001-08-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BI-PHASIC INFILTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Corp.. It received FDA 510(k) clearance on 2001-08-28 under 510(k) number K012044. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-PHASIC INFILTRATOR?

BI-PHASIC INFILTRATOR is a medical device that received FDA 510(k) clearance on 2001-08-28. The listed applicant is Reliance Medical Corp.. The 510(k) number is K012044.

When did BI-PHASIC INFILTRATOR receive FDA 510(k) clearance?

BI-PHASIC INFILTRATOR received FDA 510(k) clearance on 2001-08-28, under 510(k) number K012044.

Who is the listed applicant for BI-PHASIC INFILTRATOR?

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

What is the FDA product code for BI-PHASIC INFILTRATOR?

The FDA product code for BI-PHASIC INFILTRATOR is FRN.

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Other records listing Reliance Medical Corp. 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.

K012042KINETIC CANNULAK850704RMC ASPIRATOR - VACUUM PUMP

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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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