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FDA 510(k)

CATALOG NO. I/A 100 AND KPE 200

K-Number: K862334 · 1986-07-08

ApplicantIpax, Inc.
Decision Date1986-07-08
Product Code
DecisionSubstantially Equivalent

Device Summary

CATALOG NO. I/A 100 AND KPE 200 is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1986-07-08 under 510(k) number K862334. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATALOG NO. I/A 100 AND KPE 200?

CATALOG NO. I/A 100 AND KPE 200 is a medical device that received FDA 510(k) clearance on 1986-07-08. The listed applicant is Ipax, Inc.. The 510(k) number is K862334.

When did CATALOG NO. I/A 100 AND KPE 200 receive FDA 510(k) clearance?

CATALOG NO. I/A 100 AND KPE 200 received FDA 510(k) clearance on 1986-07-08, under 510(k) number K862334.

Who is the listed applicant for CATALOG NO. I/A 100 AND KPE 200?

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

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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.

K200893ProntoPump Sterile Tube SetK971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)K971245BLINK EXTERNAL EYELID WEIGHTK915158SUREBREATH DOME, E-Z BREATHERK915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEK914221KPE 220 TS, NONSTERILE

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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.

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