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FDA 510(k)

HS AMICA

K-Number: K083157 · 2009-09-29

ApplicantH.S Hospital Service S.P.A
Decision Date2009-09-29
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HS AMICA is the device name listed in this FDA 510(k) record. The listed applicant is H.S Hospital Service S.P.A. It received FDA 510(k) clearance on 2009-09-29 under 510(k) number K083157. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HS AMICA?

HS AMICA is a medical device that received FDA 510(k) clearance on 2009-09-29. The listed applicant is H.S Hospital Service S.P.A. The 510(k) number is K083157.

When did HS AMICA receive FDA 510(k) clearance?

HS AMICA received FDA 510(k) clearance on 2009-09-29, under 510(k) number K083157.

Who is the listed applicant for HS AMICA?

The FDA 510(k) record lists H.S Hospital Service S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HS AMICA?

The FDA product code for HS AMICA is NEY.

Related Clinical Trials

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Other records listing H.S Hospital Service S.P.A 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.

K242029TRAP EASYK232072AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18GK182605HS AMICA devices familyK033616TRAPMATIC SYSTEM SET

Related Devices (Code: NEY)

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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