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FDA 510(k)

SPIROS

K-Number: K915564 · 1992-01-30

ApplicantLife Support Products, Inc.
Decision Date1992-01-30
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROS is the device name listed in this FDA 510(k) record. The listed applicant is Life Support Products, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915564. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROS?

SPIROS is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Life Support Products, Inc.. The 510(k) number is K915564.

When did SPIROS receive FDA 510(k) clearance?

SPIROS received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915564.

Who is the listed applicant for SPIROS?

The FDA 510(k) record lists Life Support Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIROS?

The FDA product code for SPIROS is BTL.

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Other records listing Life Support Products, Inc. as applicant

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Related Devices (Code: BTL)

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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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