H-WAVE SPORT— 510(k) K081998

Substantially Equivalent

Electronic Waveform Laboratory, Inc.

FDA 510(k) clearance K081998 for H-WAVE SPORT, Substantially Equivalent on 2009-07-09. Applicant: Electronic Waveform Laboratory, Inc.. Device class: 2.

Clearance details

Applicant
Electronic Waveform Laboratory, Inc.
Product code
Code NGX
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Huntington Beach, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code NGX

view all

More clearances from Electronic Waveform Laboratory, Inc.

view all

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