DeviceClearance

V60 VENTILATOR, MODEL V8000— 510(k) K082660

Substantially Equivalent

Respironics California, Inc.

FDA 510(k) clearance K082660 for V60 VENTILATOR, MODEL V8000, Substantially Equivalent on 2009-01-09. Applicant: Respironics California, Inc.. Device class: 2.

Clearance details

Applicant
Respironics California, Inc.
Product code
Code MNT
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MNT

product code MNT
Death
118
Injury
324
Malfunction
25,451
Other
2
Total
25,895

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 K082660

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 K082660.

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