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FDA 510(k)

RESPIRONICS SEALEASY II

K-Number: K890795 · 1989-04-20

ApplicantRespironics, Inc.
Decision Date1989-04-20
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRONICS SEALEASY II is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1989-04-20 under 510(k) number K890795. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRONICS SEALEASY II?

RESPIRONICS SEALEASY II is a medical device that received FDA 510(k) clearance on 1989-04-20. The listed applicant is Respironics, Inc.. The 510(k) number is K890795.

When did RESPIRONICS SEALEASY II receive FDA 510(k) clearance?

RESPIRONICS SEALEASY II received FDA 510(k) clearance on 1989-04-20, under 510(k) number K890795.

Who is the listed applicant for RESPIRONICS SEALEASY II?

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 RESPIRONICS SEALEASY II?

The FDA product code for RESPIRONICS SEALEASY II is BSJ.

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Related Devices (Code: BSJ)

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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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