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FDA 510(k)

REMSTAR AUTO A-FLEX HT

K-Number: K131982 · 2013-10-18

ApplicantRespironics, Inc.
Decision Date2013-10-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REMSTAR AUTO A-FLEX HT is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2013-10-18 under 510(k) number K131982. 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 REMSTAR AUTO A-FLEX HT?

REMSTAR AUTO A-FLEX HT is a medical device that received FDA 510(k) clearance on 2013-10-18. The listed applicant is Respironics, Inc.. The 510(k) number is K131982.

When did REMSTAR AUTO A-FLEX HT receive FDA 510(k) clearance?

REMSTAR AUTO A-FLEX HT received FDA 510(k) clearance on 2013-10-18, under 510(k) number K131982.

Who is the listed applicant for REMSTAR AUTO A-FLEX HT?

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 REMSTAR AUTO A-FLEX HT?

The FDA product code for REMSTAR AUTO A-FLEX HT is BZD.

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Related Devices (Code: 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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