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FDA 510(k)

REVIVATOR

K-Number: K094003 · 2010-09-17

ApplicantHersill, S.L.
Decision Date2010-09-17
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REVIVATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hersill, S.L.. It received FDA 510(k) clearance on 2010-09-17 under 510(k) number K094003. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVIVATOR?

REVIVATOR is a medical device that received FDA 510(k) clearance on 2010-09-17. The listed applicant is Hersill, S.L.. The 510(k) number is K094003.

When did REVIVATOR receive FDA 510(k) clearance?

REVIVATOR received FDA 510(k) clearance on 2010-09-17, under 510(k) number K094003.

Who is the listed applicant for REVIVATOR?

The FDA 510(k) record lists Hersill, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVIVATOR?

The FDA product code for REVIVATOR is BTM.

Related Clinical Trials

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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Other records listing Hersill, S.L. 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.

K093241V7 PORTABLE SUCTION UNITS

Related Devices (Code: BTM)

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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