MEDITHERM MED2000— 510(k) K003332

Substantially Equivalent

Meditherm, Inc.

FDA 510(k) clearance K003332 for MEDITHERM MED2000, Substantially Equivalent on 2001-02-21. Applicant: Meditherm, Inc.. Device class: 1.

Clearance details

Applicant: Meditherm, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2000-10-24
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parkland, FL, US

Download summary PDF View on FDA.gov ↗

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