INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER— 510(k) K092451

Substantially Equivalent

Intersurgical, Inc.

FDA 510(k) clearance K092451 for INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER, Substantially Equivalent on 2010-10-29. Applicant: Intersurgical, Inc.. Device class: 2.

Clearance details

Applicant
Intersurgical, Inc.
Product code
Code CAH
Device class
Class 2
Regulation
21 CFR 868.5260
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Liverpool, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAH

product code CAH
Death
7
Total
7

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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