NICOLET DISPOSABLE PRASS PROBE— 510(k) K873964

Name: FDA 510(k) clearance K873964
Creator: U.S. Food and Drug Administration
Published: 1987-11-20

Substantially Equivalent

Nicolet Biomedical Instruments

FDA 510(k) clearance K873964 for NICOLET DISPOSABLE PRASS PROBE, Substantially Equivalent on 1987-11-20. Applicant: Nicolet Biomedical Instruments. Device class: 2.

Clearance details

Applicant: Nicolet Biomedical Instruments
Product code: Code ETN
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 1987-09-29
Decision date: 1987-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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K873736 — NICOLET DIGITAL TWO PIECE HEARING AID1987-12-08
K873535 — NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM1987-10-26
K871678 — NICOLET AMP 6R11 SYSTEM1987-07-16
K862592 — PHOENIX SYSTEM SEVEN.1986-09-16

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.