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FDA 510(k)

SPIROCARE 108-B

K-Number: K782016 · 1978-12-13

ApplicantMarion Laboratories, Inc.
Decision Date1978-12-13
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROCARE 108-B is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1978-12-13 under 510(k) number K782016. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROCARE 108-B?

SPIROCARE 108-B is a medical device that received FDA 510(k) clearance on 1978-12-13. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K782016.

When did SPIROCARE 108-B receive FDA 510(k) clearance?

SPIROCARE 108-B received FDA 510(k) clearance on 1978-12-13, under 510(k) number K782016.

Who is the listed applicant for SPIROCARE 108-B?

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

What is the FDA product code for SPIROCARE 108-B?

The FDA product code for SPIROCARE 108-B is BWF.

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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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