ROKONICS SENTRY MODEL 8500— 510(k) K851819

Substantially Equivalent

Rokonics, Inc.

FDA 510(k) clearance K851819 for ROKONICS SENTRY MODEL 8500, Substantially Equivalent on 1986-01-21. Applicant: Rokonics, Inc.. Device class: 2.

Clearance details

Applicant: Rokonics, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1985-04-26
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Rokonics, Inc.

K871576 — ROKONICS 85001987-07-16

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