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FDA 510(k)

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01

K-Number: K060289 · 2006-07-07

ApplicantFrontline Medical
Decision Date2006-07-07
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 is the device name listed in this FDA 510(k) record. The listed applicant is Frontline Medical. It received FDA 510(k) clearance on 2006-07-07 under 510(k) number K060289. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01?

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Frontline Medical. The 510(k) number is K060289.

When did EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 receive FDA 510(k) clearance?

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 received FDA 510(k) clearance on 2006-07-07, under 510(k) number K060289.

Who is the listed applicant for EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01?

The FDA 510(k) record lists Frontline Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01?

The FDA product code for EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 is KNA.

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Related Devices (Code: KNA)

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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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