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FDA 510(k)

KOKO FILTER II

K-Number: K934475 · 1993-10-21

ApplicantPulmonary Data Services Inst., Inc.
Decision Date1993-10-21
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KOKO FILTER II is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonary Data Services Inst., Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K934475. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOKO FILTER II?

KOKO FILTER II is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Pulmonary Data Services Inst., Inc.. The 510(k) number is K934475.

When did KOKO FILTER II receive FDA 510(k) clearance?

KOKO FILTER II received FDA 510(k) clearance on 1993-10-21, under 510(k) number K934475.

Who is the listed applicant for KOKO FILTER II?

The FDA 510(k) record lists Pulmonary Data Services Inst., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOKO FILTER II?

The FDA product code for KOKO FILTER II is CAH.

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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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