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FDA 510(k)

PEERSCOPE SYSTEM

K-Number: K130718 · 2013-04-16

ApplicantPeermedical , Ltd.
Decision Date2013-04-16
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEERSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Peermedical , Ltd.. It received FDA 510(k) clearance on 2013-04-16 under 510(k) number K130718. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEERSCOPE SYSTEM?

PEERSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-16. The listed applicant is Peermedical , Ltd.. The 510(k) number is K130718.

When did PEERSCOPE SYSTEM receive FDA 510(k) clearance?

PEERSCOPE SYSTEM received FDA 510(k) clearance on 2013-04-16, under 510(k) number K130718.

Who is the listed applicant for PEERSCOPE SYSTEM?

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

What is the FDA product code for PEERSCOPE SYSTEM?

The FDA product code for PEERSCOPE SYSTEM is FDF.

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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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