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FDA 510(k)

MODIFIED SANDERS BI-PAPEASY

K-Number: K883825 · 1988-12-08

ApplicantRespironics, Inc.
Decision Date1988-12-08
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED SANDERS BI-PAPEASY is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1988-12-08 under 510(k) number K883825. 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 MODIFIED SANDERS BI-PAPEASY?

MODIFIED SANDERS BI-PAPEASY is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Respironics, Inc.. The 510(k) number is K883825.

When did MODIFIED SANDERS BI-PAPEASY receive FDA 510(k) clearance?

MODIFIED SANDERS BI-PAPEASY received FDA 510(k) clearance on 1988-12-08, under 510(k) number K883825.

Who is the listed applicant for MODIFIED SANDERS BI-PAPEASY?

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 MODIFIED SANDERS BI-PAPEASY?

The FDA product code for MODIFIED SANDERS BI-PAPEASY 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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