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FDA 510(k)

BIPAP PRO BI-LEVEL SYSTEM

K-Number: K011714 · 2001-06-28

ApplicantRespironics, Inc.
Decision Date2001-06-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP PRO BI-LEVEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2001-06-28 under 510(k) number K011714. 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 BIPAP PRO BI-LEVEL SYSTEM?

BIPAP PRO BI-LEVEL SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Respironics, Inc.. The 510(k) number is K011714.

When did BIPAP PRO BI-LEVEL SYSTEM receive FDA 510(k) clearance?

BIPAP PRO BI-LEVEL SYSTEM received FDA 510(k) clearance on 2001-06-28, under 510(k) number K011714.

Who is the listed applicant for BIPAP PRO BI-LEVEL SYSTEM?

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 BIPAP PRO BI-LEVEL SYSTEM?

The FDA product code for BIPAP PRO BI-LEVEL SYSTEM is BZD.

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Related Devices (Code: BZD)

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

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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