Pulse Rx 2.0, Pulse Pro Rx 2.0— 510(k) K183328

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K183328 for Pulse Rx 2.0, Pulse Pro Rx 2.0, Substantially Equivalent on 2018-12-21. Applicant: NormaTec Industries, LP.

Clearance details

Applicant
NormaTec Industries, LP
Product code
Code JOW
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Watertown, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.