DeviceClearance

ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE— 510(k) K093525

Substantially Equivalent

Ventlab Corp.

FDA 510(k) clearance K093525 for ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE, Substantially Equivalent on 2009-12-10. Applicant: Ventlab Corp.. Device class: 2.

Clearance details

Applicant
Ventlab Corp.
Product code
Code CCK
Device class
Class 2
Regulation
21 CFR 868.1400
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mocksville, NC, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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 K093525

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 K093525.

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