PAM-RL— 510(k) K010997

Substantially Equivalent

Individual Monitoring Systems, Inc.

FDA 510(k) clearance K010997 for PAM-RL, Substantially Equivalent on 2001-10-15. Applicant: Individual Monitoring Systems, Inc.. Device class: 2.

Clearance details

Applicant
Individual Monitoring Systems, Inc.
Product code
Code GWQ
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Baltimore, MD, US
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