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FDA 510(k)

INFOSEND GSM

K-Number: K110316 · 2011-08-19

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2011-08-19
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFOSEND GSM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K110316. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFOSEND GSM?

INFOSEND GSM is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K110316.

When did INFOSEND GSM receive FDA 510(k) clearance?

INFOSEND GSM received FDA 510(k) clearance on 2011-08-19, under 510(k) number K110316.

Who is the listed applicant for INFOSEND GSM?

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

What is the FDA product code for INFOSEND GSM?

The FDA product code for INFOSEND GSM is BZD.

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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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