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FDA 510(k)

PERICAM PSI

K-Number: K120884 · 2012-07-03

ApplicantPerimed AB
Decision Date2012-07-03
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERICAM PSI is the device name listed in this FDA 510(k) record. The listed applicant is Perimed AB. It received FDA 510(k) clearance on 2012-07-03 under 510(k) number K120884. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERICAM PSI?

PERICAM PSI is a medical device that received FDA 510(k) clearance on 2012-07-03. The listed applicant is Perimed AB. The 510(k) number is K120884.

When did PERICAM PSI receive FDA 510(k) clearance?

PERICAM PSI received FDA 510(k) clearance on 2012-07-03, under 510(k) number K120884.

Who is the listed applicant for PERICAM PSI?

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

What is the FDA product code for PERICAM PSI?

The FDA product code for PERICAM PSI is DPT.

Related Clinical Trials

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Other records listing Perimed AB 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.

K152930PeriFlux6000K131253PERIFLUX 6000K011899PF 5050 PRESSURE UNIT, MODEL PF 5050

Related Devices (Code: DPT)

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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