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FDA 510(k)

Simple T Pediatric Nasal Mask

K-Number: K151120 · 2016-04-15

ApplicantRespironics, Inc.
Decision Date2016-04-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Simple T Pediatric Nasal Mask is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval number K151120. 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 Simple T Pediatric Nasal Mask?

Simple T Pediatric Nasal Mask is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Respironics, Inc.. The 510(k) number is K151120.

When was Simple T Pediatric Nasal Mask approved by the FDA?

Simple T Pediatric Nasal Mask received FDA 510(k) clearance on 2016-04-15, under approval number K151120.

What company makes Simple T Pediatric Nasal Mask?

Simple T Pediatric Nasal Mask is manufactured by Respironics, Inc..

What is the FDA product code for Simple T Pediatric Nasal Mask?

The FDA product code for Simple T Pediatric Nasal Mask 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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