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FDA 510(k)

RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01

K-Number: K013200 · 2001-12-14

ApplicantRennels Medical Corp.
Decision Date2001-12-14
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 is the device name listed in this FDA 510(k) record. The listed applicant is Rennels Medical Corp.. It received FDA 510(k) clearance on 2001-12-14 under 510(k) number K013200. 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 RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01?

RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is Rennels Medical Corp.. The 510(k) number is K013200.

When did RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 receive FDA 510(k) clearance?

RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013200.

Who is the listed applicant for RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01?

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

What is the FDA product code for RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01?

The FDA product code for RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 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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