DeviceClearance

RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR— 510(k) K941252

Substantially Equivalent

Ansar

FDA 510(k) clearance K941252 for RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR, Substantially Equivalent on 1995-09-20. Applicant: Ansar. Device class: 2.

Clearance details

Applicant
Ansar
Product code
Code DRT
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Philidelphia, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DRT

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Adverse events under product code DRT

product code DRT
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 →

Recalls naming K941252

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 K941252.

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