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FDA 510(k)

Surveyor S2

K-Number: K182297 · 2019-01-24

ApplicantMortara Instrument, Inc.
Decision Date2019-01-24
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surveyor S2 is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2019-01-24 under 510(k) number K182297. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surveyor S2?

Surveyor S2 is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K182297.

When did Surveyor S2 receive FDA 510(k) clearance?

Surveyor S2 received FDA 510(k) clearance on 2019-01-24, under 510(k) number K182297.

Who is the listed applicant for Surveyor S2?

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

What is the FDA product code for Surveyor S2?

The FDA product code for Surveyor S2 is DRG.

Other records listing Mortara Instrument, Inc. 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.

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Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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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