DeviceClearance

MANUAL PULMONARY RESUSICITATOR— 510(k) K953546

Substantially Equivalent

Medical Marketing Concepts

FDA 510(k) clearance K953546 for MANUAL PULMONARY RESUSICITATOR, Substantially Equivalent on 1996-02-29. Applicant: Medical Marketing Concepts. Device class: 2.

Clearance details

Applicant
Medical Marketing Concepts
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
Hardy, VA, US
Download summary PDFView on FDA.gov ↗

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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 →

Recalls naming K953546

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 K953546.

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