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FDA 510(k)

SURECALL LABOR MONITOR

K-Number: K130002 · 2013-06-28

ApplicantReproductive Research Technologies, LP
Decision Date2013-06-28
Product CodeOSP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURECALL LABOR MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Reproductive Research Technologies, LP. It received FDA 510(k) clearance on 2013-06-28 under 510(k) number K130002. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURECALL LABOR MONITOR?

SURECALL LABOR MONITOR is a medical device that received FDA 510(k) clearance on 2013-06-28. The listed applicant is Reproductive Research Technologies, LP. The 510(k) number is K130002.

When did SURECALL LABOR MONITOR receive FDA 510(k) clearance?

SURECALL LABOR MONITOR received FDA 510(k) clearance on 2013-06-28, under 510(k) number K130002.

Who is the listed applicant for SURECALL LABOR MONITOR?

The FDA 510(k) record lists Reproductive Research Technologies, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURECALL LABOR MONITOR?

The FDA product code for SURECALL LABOR MONITOR is OSP.

Related Clinical Trials

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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Other records listing Reproductive Research Technologies, LP 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.

K090145SURECALL EMG LABOR MONITOR

Related Devices (Code: OSP)

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.

K190798LaborView™ LV1000 Wireless Electrode SystemObmedical CompanyK153262PUREtrace™Nemo Healthcare BVK112390MONICA AN24Monica Healthcare, Ltd.K112163MONICA IF24Monica HealthcareK101801MONICA AN24Monica HealthcareK090145SURECALL EMG LABOR MONITORReproductive Research Technologies, LP

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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