DISPOSABLE BERMAN AND GUEDEL AIRWAYS— 510(k) K861540

Substantially Equivalent

Dryden Corp.

FDA 510(k) clearance K861540 for DISPOSABLE BERMAN AND GUEDEL AIRWAYS, Substantially Equivalent on 1986-05-02. Applicant: Dryden Corp.. Device class: 1.

Clearance details

Applicant
Dryden Corp.
Product code
Code CAE
Device class
Class 1
Regulation
21 CFR 868.5110
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAE

product code CAE
Death
4
Total
4

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 →

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