BOMED-EEA— 510(k) K853705

Name: FDA 510(k) clearance K853705
Creator: U.S. Food and Drug Administration
Published: 1986-01-13

Substantially Equivalent

Bomed Medical Mfr., Ltd.

FDA 510(k) clearance K853705 for BOMED-EEA, Substantially Equivalent on 1986-01-13. Applicant: Bomed Medical Mfr., Ltd.. Device class: 2.

Clearance details

Applicant: Bomed Medical Mfr., Ltd.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1985-09-04
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Bomed Medical Mfr., Ltd.

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K853706 — BOMED-CDM1986-04-14
K831421 — BOMED BIOCON1983-09-12
K831422 — BIOFLOW1983-09-12
K830792 — PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE1983-03-29
K813020 — BOMED-NCCOM1981-12-14

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.