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FDA 510(k)

COUGHASSIST T70 DEVICE

K-Number: K121955 · 2012-12-14

ApplicantRespironics, Inc.
Decision Date2012-12-14
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COUGHASSIST T70 DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K121955. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUGHASSIST T70 DEVICE?

COUGHASSIST T70 DEVICE is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Respironics, Inc.. The 510(k) number is K121955.

When did COUGHASSIST T70 DEVICE receive FDA 510(k) clearance?

COUGHASSIST T70 DEVICE received FDA 510(k) clearance on 2012-12-14, under 510(k) number K121955.

Who is the listed applicant for COUGHASSIST T70 DEVICE?

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

What is the FDA product code for COUGHASSIST T70 DEVICE?

The FDA product code for COUGHASSIST T70 DEVICE is NHJ.

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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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