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Actiwave 1e, Actiwave2e, Actiwave2m, Actiwave4e, Actiwave Cardio (08-514 +4 mor… - 08-557

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100266

by CamNtech Ltd

Identifiers

510(k) Number
K100266 FDA 510(k)
FDA Product Code
MWJ FDA 510(k)
Models / Variants
08-514 FDA 510(k)
08-521 FDA 510(k)
08-536 FDA 510(k)
08-557 FDA 510(k)
08-603 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2800 FDA 510(k)
Regulation Number
870.2800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Actiwave 1e, Actiwave2e, Actiwave2m, Actiwave4e, Actiwave Cardio (08-514 +4 mor… - 08-557 by CamNtech Ltd — Class II — FDA_510K — listed in FDA 510(k) — 5…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CamNtech Ltd
FDA Applicant
Camntech, Ltd.

Sources (1)

  • FDA 510(k) K100266 24 fields · synced Jun 18, 2026