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FDA 510(k)

HIVOX Spopad EMS SP-911, SP-921

K-Number: K192264 · 2019-11-08

ApplicantHivox Biotek, Inc.
Decision Date2019-11-08
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HIVOX Spopad EMS SP-911, SP-921 is the device name listed in this FDA 510(k) record. The listed applicant is Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K192264. 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 HIVOX Spopad EMS SP-911, SP-921?

HIVOX Spopad EMS SP-911, SP-921 is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K192264.

When did HIVOX Spopad EMS SP-911, SP-921 receive FDA 510(k) clearance?

HIVOX Spopad EMS SP-911, SP-921 received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192264.

Who is the listed applicant for HIVOX Spopad EMS SP-911, SP-921?

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

What is the FDA product code for HIVOX Spopad EMS SP-911, SP-921?

The FDA product code for HIVOX Spopad EMS SP-911, SP-921 is NGX.

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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

View on FDA Database →

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

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