MEDICOOL— 510(k) K923643

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K923643 for MEDICOOL, Substantially Equivalent on 1993-03-31. Applicant: Micromedic Systems. Device class: 2.

Clearance details

Applicant: Micromedic Systems
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1992-07-21
Decision date: 1993-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coleman, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILO

K213097 — Armory Motion2022-06-10
K083008 — COOLSKIN2009-06-10
K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP2008-05-08
K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE2007-09-07
K070402 — MODIFICATION TO POLAR CARE 5002007-03-29

More clearances from Micromedic Systems

K872309 — MICROMEDIC COMBOSTAT LH/FSH KIT1987-07-31
K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26
K871008 — MICROMEDIC NEONATAL T4 KIT1987-05-26
K871505 — AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26
K870245 — AUTOPAK TSH MONOCLONAL IRMA KIT1987-04-01

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