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FDA 510(k)

IP-16

K-Number: K980301 · 1998-03-24

ApplicantServizi Medico Estetici Italinai Srl.
Decision Date1998-03-24
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IP-16 is the device name listed in this FDA 510(k) record. The listed applicant is Servizi Medico Estetici Italinai Srl.. It received FDA 510(k) clearance on 1998-03-24 under 510(k) number K980301. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IP-16?

IP-16 is a medical device that received FDA 510(k) clearance on 1998-03-24. The listed applicant is Servizi Medico Estetici Italinai Srl.. The 510(k) number is K980301.

When did IP-16 receive FDA 510(k) clearance?

IP-16 received FDA 510(k) clearance on 1998-03-24, under 510(k) number K980301.

Who is the listed applicant for IP-16?

The FDA 510(k) record lists Servizi Medico Estetici Italinai Srl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IP-16?

The FDA product code for IP-16 is BTA.

Other records listing Servizi Medico Estetici Italinai Srl. 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.

K971609SCULPTURE

Related Devices (Code: BTA)

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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