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FDA 510(k)

H-WAVE SPORT

K-Number: K081998 · 2009-07-09

ApplicantElectronic Waveform Laboratory, Inc.
Decision Date2009-07-09
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

H-WAVE SPORT is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Waveform Laboratory, Inc.. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K081998. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-WAVE SPORT?

H-WAVE SPORT is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Electronic Waveform Laboratory, Inc.. The 510(k) number is K081998.

When did H-WAVE SPORT receive FDA 510(k) clearance?

H-WAVE SPORT received FDA 510(k) clearance on 2009-07-09, under 510(k) number K081998.

Who is the listed applicant for H-WAVE SPORT?

The FDA 510(k) record lists Electronic Waveform Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-WAVE SPORT?

The FDA product code for H-WAVE SPORT is NGX.

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Other records listing Electronic Waveform Laboratory, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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