ORTHO TECH CRYOLOGIC SYSTEM— 510(k) K940429

Name: FDA 510(k) clearance K940429
Creator: U.S. Food and Drug Administration
Published: 1994-07-12

Substantially Equivalent for Some Indications

Orthopedic Technology, Inc.

FDA 510(k) clearance K940429 for ORTHO TECH CRYOLOGIC SYSTEM, Substantially Equivalent for Some Indications on 1994-07-12. Applicant: Orthopedic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Technology, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1994-01-31
Decision date: 1994-07-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Tracy, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILO

view all

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 Orthopedic Technology, Inc.

view all

K843780 — VENT-A-CAST1984-11-14

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