MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A— 510(k) K993169

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K993169 for MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A, Substantially Equivalent on 1999-12-20. Applicant: Hewlett-Packard Co.. Device class: 2.

Clearance details

Applicant
Hewlett-Packard Co.
Product code
Code DRG
Device class
Class 2
Regulation
21 CFR 870.2910
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Altos, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DRG

product code DRG
Death
5
Total
5

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.