OUTPUT DIGITAL DISPLAY MODULE, MOD. 611— 510(k) K800360

Name: FDA 510(k) clearance K800360
Creator: U.S. Food and Drug Administration
Published: 1980-02-29

Substantially Equivalent

Output, Inc.

FDA 510(k) clearance K800360 for OUTPUT DIGITAL DISPLAY MODULE, MOD. 611, Substantially Equivalent on 1980-02-29. Applicant: Output, Inc.. Device class: 2.

Clearance details

Applicant: Output, Inc.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1980-02-20
Decision date: 1980-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSK

view all

K231586 — Endophys Blood Pressure Monitor model BPM-302023-11-03
K160945 — Endophys Blood Pressure Monitor2016-09-26
K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box2015-12-03
K141615 — ENDOPHYS BLOOD PRESSURE MONITOR2015-01-07
K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM2008-04-23

More clearances from Output, Inc.

view all

K781115 — PRINTER, DIGITAL1978-10-06
K780356 — OUTPUT DIGITAL DISPLAY MODULE, MODEL 4011978-05-31
K770987 — NERVE STIMULATOR, MOLEL NO. FB-8001977-06-14
K760614 — PERIPHERAL NERVE STIMULATOR1976-11-19

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