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FDA 510(k)

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)

K-Number: K131009 · 2013-05-07

ApplicantProteus Digital Health, Inc.
Decision Date2013-05-07
Product CodeOZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) is the device name listed in this FDA 510(k) record. The listed applicant is Proteus Digital Health, Inc.. It received FDA 510(k) clearance on 2013-05-07 under 510(k) number K131009. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)?

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) is a medical device that received FDA 510(k) clearance on 2013-05-07. The listed applicant is Proteus Digital Health, Inc.. The 510(k) number is K131009.

When did PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) receive FDA 510(k) clearance?

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) received FDA 510(k) clearance on 2013-05-07, under 510(k) number K131009.

Who is the listed applicant for PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)?

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

What is the FDA product code for PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)?

The FDA product code for PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) is OZW.

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 Proteus Digital Health, 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.

K131524PROTEUS PATCH INCLUDING INGESTIBLE SENSOR

Related Devices (Code: OZW)

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.

K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.K183052ID-Cap SystemEtectrx, Inc.K131524PROTEUS PATCH INCLUDING INGESTIBLE SENSORProteus Digital Health, Inc.

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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