PINWHEEL— 510(k) K780422

Substantially Equivalent

Projects IN Health

FDA 510(k) clearance K780422 for PINWHEEL, Substantially Equivalent on 1978-04-04. Applicant: Projects IN Health. Device class: 1.

Clearance details

Applicant: Projects IN Health
Product code: Code GWY
Device class: Class 1
Regulation: 21 CFR 882.1750
Advisory panel: Neurology
Date received: 1978-03-17
Decision date: 1978-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWY

K050313 — BIS SRS (SEMI-RESUABLE SENSOR)2005-02-24
K942926 — NEURO-AIDE1994-08-03
K871167 — SENSITESTER1987-04-01
K851749 — 1-380 PINWHEEL (WARTENBERG)1985-06-13

More clearances from Projects IN Health

K781224 — METER, FLOW, PEAK1978-10-15
K770580 — PEAK FLOW METER1977-08-04

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