DeviceClearance

CLEARVIEW BLOWER/MISTER— 510(k) K973485

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K973485 for CLEARVIEW BLOWER/MISTER, Substantially Equivalent on 1997-12-08. Applicant: Dlp, Inc.. Device class: 2.

Clearance details

Applicant
Dlp, Inc.
Product code
Code FQH
Device class
Class 2
Regulation
21 CFR 880.5475
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Grand Rapids, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FQH

product code FQH
Injury
170
Malfunction
2,513
Other
1
Total
2,684

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 K973485

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 K973485.

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