FDA 510(k)

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER

K-Number: K092451 · 2010-10-29

Decision Date2010-10-29

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical, Inc.. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K092451. 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 INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER?

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Intersurgical, Inc.. The 510(k) number is K092451.

When did INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER receive FDA 510(k) clearance?

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER received FDA 510(k) clearance on 2010-10-29, under 510(k) number K092451.

Who is the listed applicant for INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER?

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

What is the FDA product code for INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER?

The FDA product code for INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER is CAH.

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Other records listing Intersurgical, Inc. as applicant

K122077MANOMETER K122075DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER K121026FLO-GUARD BREATHING FILTER K092129INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER K032322CLEAR-THERM MICRO HME, MODEL 1441

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Related Devices (Code: CAH)

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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.