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FDA 510(k)

SANDER'S MASKCPAP BY RESPIRONICS

K-Number: K851396 · 1985-05-15

ApplicantRespironics, Inc.
Decision Date1985-05-15
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SANDER'S MASKCPAP BY RESPIRONICS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K851396. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDER'S MASKCPAP BY RESPIRONICS?

SANDER'S MASKCPAP BY RESPIRONICS is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Respironics, Inc.. The 510(k) number is K851396.

When did SANDER'S MASKCPAP BY RESPIRONICS receive FDA 510(k) clearance?

SANDER'S MASKCPAP BY RESPIRONICS received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851396.

Who is the listed applicant for SANDER'S MASKCPAP BY RESPIRONICS?

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 SANDER'S MASKCPAP BY RESPIRONICS?

The FDA product code for SANDER'S MASKCPAP BY RESPIRONICS is BYE.

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Related Devices (Code: BYE)

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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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