DeviceClearance

CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R— 510(k) K063758

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K063758 for CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R, Substantially Equivalent on 2007-04-23. Applicant: Teleflex Medical. Device class: 2.

Clearance details

Applicant
Teleflex Medical
Product code
Code BTT
Device class
Class 2
Regulation
21 CFR 868.5450
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bannockburn, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code BTT

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More clearances from Teleflex Medical

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Adverse events under product code BTT

product code BTT
Death
60
Injury
152
Malfunction
7,232
Other
2
Total
7,446

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 →

Recalls naming K063758

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063758.

Data sourced from openFDA. This site is unofficial and independent of the FDA.