ELECTRODES, FERRIS ECG, TYPES 905,906— 510(k) K790305

Name: FDA 510(k) clearance K790305
Creator: U.S. Food and Drug Administration
Published: 1979-04-03

Substantially Equivalent

Ferris Mfg. Corp.

FDA 510(k) clearance K790305 for ELECTRODES, FERRIS ECG, TYPES 905,906, Substantially Equivalent on 1979-04-03. Applicant: Ferris Mfg. Corp.. Device class: 2.

Clearance details

Applicant: Ferris Mfg. Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1979-02-13
Decision date: 1979-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2010-07-22
K101685 — IP-SET2010-07-01

More clearances from Ferris Mfg. Corp.

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K031660 — FERRIS POLYMEM STERILE BREAST PAD2005-02-22
K031307 — FERRIS POLYMEM SILVER WOUND DRESSING2003-10-22
K002129 — FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN2000-08-25
K991729 — FERRIS POLYOSTOMY STERILE WOUND DRESSING1999-08-27
K990906 — FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER1999-04-29

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.