DeviceClearance

CPR HEARTSAVER AND BREATHOLATOR— 510(k) K831198

Substantially Equivalent

Cervco Corp.

FDA 510(k) clearance K831198 for CPR HEARTSAVER AND BREATHOLATOR, Substantially Equivalent on 1983-06-24. Applicant: Cervco Corp.. Device class: 2.

Clearance details

Applicant
Cervco Corp.
Product code
Code BTM
Device class
Class 2
Regulation
21 CFR 868.5915
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code BTM

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Adverse events under product code BTM

product code BTM
Death
19
Other
2
Total
21

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.