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FDA 510(k)

PeraMobile and PeraWatch

K-Number: K183370 · 2019-09-11

ApplicantPerahealth, Inc.
Decision Date2019-09-11
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PeraMobile and PeraWatch is the device name listed in this FDA 510(k) record. The listed applicant is Perahealth, Inc.. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K183370. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeraMobile and PeraWatch?

PeraMobile and PeraWatch is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Perahealth, Inc.. The 510(k) number is K183370.

When did PeraMobile and PeraWatch receive FDA 510(k) clearance?

PeraMobile and PeraWatch received FDA 510(k) clearance on 2019-09-11, under 510(k) number K183370.

Who is the listed applicant for PeraMobile and PeraWatch?

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

What is the FDA product code for PeraMobile and PeraWatch?

The FDA product code for PeraMobile and PeraWatch is MWI.

Other records listing Perahealth, 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: MWI)

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

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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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