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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 a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval 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. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K192264.

When was HIVOX Spopad EMS SP-911, SP-921 approved by the FDA?

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

What company makes HIVOX Spopad EMS SP-911, SP-921?

HIVOX Spopad EMS SP-911, SP-921 is manufactured by Hivox Biotek, Inc..

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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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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